Indications – Kepplah Wed, 16 Nov 2022 19:33:17 +0000 en-US hourly 1 Indications – Kepplah 32 32 NATO chief says no missile indicates missile in Poland was deliberate Wed, 16 Nov 2022 19:21:28 +0000


NATO Secretary General Jens Stoltenberg said the explosion in eastern Poland that killed two people was likely caused by a Ukrainian air defense missile, but that Russia was responsible in last resort because it triggered the war in Ukraine.

His speech followed an emergency meeting to respond to a grain dryer explosion near the Ukrainian border, which occurred as Russia fired dozens of missiles at towns across Ukraine.

Soltenberg said one of NATO’s main priorities right now is to provide more air defense systems to Ukraine.

Polish President Andrzei Duda said earlier it was “highly probable” the missile was fired by Ukraine’s air defence.

Britain will not rush to judge the origin of the missile

“We are not going to rush to judgment. Our response will always be guided by facts,” British Foreign Secretary James Cleverly said in a speech to the British Parliament on Wednesday, adding that the investigation into the incident would be led by Poland.

Mr Cleverly’s warning came after NATO Secretary General Jens Stoltenberg’s press conference in Brussels, where he said “preliminary analysis suggests the incident was likely caused by a Ukrainian air defense fired to defend Ukrainian territory against Russian cruise missile attacks”.

The foreign minister condemned Putin’s “brutal air campaign” over Ukraine on Tuesday, when waves of missiles hit cities across the country.

Ukraine calls for evidence of a ‘Russian trace’

Ukraine wanted a joint study of Tuesday’s incident with its partners and to see the information that served as the basis for its allies.

Oleksiy Danilov, secretary of Ukraine’s National Security and Defense Council, said Ukraine wanted access to the site of the blast.

Ukraine wants access to an explosion site in Poland that may have been caused by its missile.

Kyiv is “completely open to a thorough study of the situation”, he wrote on the council’s official Facebook page on Wednesday.

Danilov echoed Ukrainian President Volodymyr Zelenskiy in blaming Russia’s “missile terror”. Danilov did not provide any details of the evidence he was citing when he referred to a “Russian trace” behind the incident.

Asked whether Poland would grant Ukraine access to the blast site and agree to a joint study, Polish Foreign Ministry spokesman Lukasz Jasina wrote via email: “We don’t let’s not comment on this case”.

—with the AAP

India: India-EU trade pact: next round of negotiations from the end of November Sun, 13 Nov 2022 16:00:00 +0000 The next round of talks between India and the European Union (EU) on a draft free trade agreement, which aims to boost trade and investment between the two regions, is expected to start at the end of this month. , said an official. India and the EU formally resumed negotiations on the proposed deal on June 17 this year, after a hiatus of more than eight years.

“The EU delegation will be here on November 28 for the third round of negotiations on the India-EU Trade and Investment Agreement, including Geographical Indications (GIs),” said the responsible.

The second round of negotiations took place in Brussels.

India’s bilateral trade with the EU grew by 43.5% to $116.36 billion in 2021-22.

Currently, the EU is India’s second largest trading partner after the United States and the second largest destination for Indian exports.

According to the Ministry of Commerce, the trade agreement with the EU would help India further develop and diversify its exports of goods and services, including by securing value chains.

Both parties want trade negotiations to be broad, balanced and comprehensive, based on the principles of equity and reciprocity.

A GI is mainly an agricultural, natural or manufactured product (artisanal and industrial products) originating from a specific geographical territory. Typically, such a name conveys an assurance of quality and distinctiveness, which is essentially attributable to the place of its origin.

Regulator recognizes Imfinzi indication for bile duct cancer Fri, 11 Nov 2022 06:43:31 +0000

A new treatment method developed by domestic researchers and improved overall survival (OS) of biliary tract cancer patients in the primary treatment stage have won approval from the government regulatory body.

On Thursday, the Ministry of Food and Drug Safety approved the combination therapy of Imfinzi (durvalumab) and Gemcitabine/Cisplatin (GemCis) as the primary treatment for adults with locally progressive or metastatic biliary tract cancer.

On Thursday, the Ministry of Food and Drug Safety approved the combination of Imfinzi (durvalumab) and Gemcitabine/Cisplatin (GemCis) as the primary treatment for adults with locally progressive or metastatic biliary tract cancer.

Imfinzi + GemCis combination therapy is the first treatment that opened the door to immunotherapy in biliary tract cancer and the only therapy that has been shown to improve OS compared to GemCis single therapy which served as the standard treatment over the past twelve years.

It is all the more significant that national researchers have taken the lead in the successful conduct of the TOPAZ-1 study, the global Phase 3 clinical trial that served as the basis for the approval of the combination therapy Imfinzi + GemCis.

Oh Do-youn from Department of Hematology-Oncology at Seoul National University Hospital successfully completed TOPAZ-1 study based on positive result of investigator-led Phase 2 clinical trial on patients Koreans, rewriting the treatment paradigm for progressive bile duct cancer.

The TOPAZ-1 study is a multinational, randomized, double-blind, placebo-controlled Phase 2 study that combined Imfinzi with the existing standard treatment of GemCis and compared and evaluated it with a placebo combination therapy in 685 patients with progressive bile duct cancer.

Patient registration for this study was conducted in 17 countries, including the United States, Europe, and Latin America, and 55% of them were conducted in Asian countries, including Korea, Thailand, Japan and China.

According to research data updated in the New England Journal of Medicine (NEJM) Evidence in June, the hazard ratio (HR) of SG of the Imfinzi + GemCis group was 0.80 compared to the GemCis + placebo group, reducing the risk of death by approximately 20%. OS during the second year was 24.9% for the Imfinzi combination therapy group and 10.4% for the placebo combination therapy group.

The occupation-free survival (PFS) rate was 0.75, meaning that Imfinzi combination therapy reduced disease progression and risk of death by 25% compared to the placebo combination therapy group. Additionally, the objective response rate (ORR) of the Imfinzi-combo and placebo combo groups was 26.7% versus 18.7%.

On the other hand, the occurrence rates of abnormal reactions with 3-4 grades were similar in both groups – 75.7% versus 77.8%. The most commonly reported side effects were anemia (48.2%), neutropenia (31.7%) and nausea (40.2%), indicating that most side effects were caused by chemotherapy.

Based on the results of these studies, the combination therapy Imfinzi + GemCis obtained approval from the United States Food and Drug Administration in early September. It was the first approved primary treatment method for progressive bile duct cancer in 12 years since GemCis won FDA approval based on a Phase 3 clinical trial of the ABC- 02 in 2010.

The Korean government’s approval came two months after the US FDA’s approval, indicating that the clearance review process took place almost simultaneously in both countries. For this reason, the developers expect regulatory authorities to quickly provide insurance benefits for the Imfinzi + GemCis combination therapy.

As reasons for their optimistic prediction, the developers cited poor treatment records for bile duct cancer, few treatment options available in Korea, and strong domestic patient data based on phase 2 and 3 clinical trials. , including SG data, making driving easier. examination for reimbursement.

Additionally, international academic journals are likely to recognize the Imfinzi + GemCis combination therapy as the new standard therapy as the primary treatment for progressive bile duct cancer, adding to the grounds for reimbursement, industry executives said.

Varadkar says there is no indication the tech giants will close Irish offices Tue, 08 Nov 2022 08:54:48 +0000

Leo Varadkar said the government has asked IDA Ireland and Enterprise Ireland to step up their engagement with major tech employers in Ireland.

Tánaiste Leo Varadkar, TD, said there was no indication that big tech companies were planning to shut down their Irish operations altogether.

Varadkar released the statement after a meeting with IDA Ireland and Enterprise Ireland. This follows recent massive job cuts at Twitter and Bandaged.

The Tánaiste and Minister for Enterprise, Trade and Employment said the meeting followed “a series of direct contacts” between his office and the agencies with the companies involved.

“My main concern is with the staff and their families who will be affected by downsizing at some of the technology companies operating in Ireland,” Varadkar said. “We will assist all affected employees in their search for alternative employment or other opportunities.”

In Ireland, employers proposing collective redundancies must first consult with employee representatives. Companies are also required to inform the government in advance. However, neither Twitter nor Stripe informed the Enterprise Department of their plans to cut staff.

“There are well-established statutory processes to protect employees, and we are confident that all national employment rights requirements for consultation and notification of redundancies will be met once decisions on any job cuts are made. will be taken,” Varadkar said.

Employers must also have a genuine business reason to terminate employees and must use fair and reasonable selection criteria in deciding who to terminate. The penalty for not following this procedure can be up to €250,000 and can also result in prosecution for unfair dismissal.

Irish weather reported last week, Stripe has entered into a 30-day consultation period with its Irish staff.

There are growing fears that Meta, the parent company of Facebook, Instagram and WhatsApp, is also plan a big discount in its global workforce.

Around 3,000 people are employed by Meta in Ireland, across its European headquarters in Dublin, its Reality Labs team in Cork and its data center in Clonee, Co Meath.

It comes amid a wider wave of layoffs in the tech sector. Job losses at Stripe and Twitter follow staff cuts at Instantaneous, Patreon and Intercomamong others. Intel also confirmed that it was considering cutting jobs amid continued declines in global PC sales.

Despite funding cuts affecting the tech sector in Ireland, Varadkar said the country was close to full employment and there was “high demand” for tech, marketing and other skills across all sectors.

“There is a strong pipeline of new investment from overseas and in Ireland across a range of sectors, including technology and beyond, and we expect many positive announcements in the months ahead” , he added.

“We have ongoing engagement with major tech employers through IDA and Enterprise Ireland, and the government has asked the agencies to step up that engagement.”

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Leo Varadkar at the RDS in Dublin in 2018. Image: Eóin Noonan/MoneyConf via Flickr (CC by 2.0)

Ivan Toney was investigated by the FA over historic gambling allegations for SEVEN MONTHS Sat, 05 Nov 2022 20:39:51 +0000

EXCLUSIVE: World Cup hopeful Ivan Toney has been investigated by the FA over historic gambling allegations for SEVEN MONTHS without reaching a conclusion… but there is no indication the Brentford star has never bet against his team

  • Ivan Toney under FA investigation over historic gambling allegations
  • The Brentford man has not been charged and the investigation is still incomplete
  • The alleged gambling activity took place before his transfer to west London

England World Cup hopeful Ivan Toney is being investigated by the FA over allegations he played football.

Toney has not been charged with any offences, but the investigation is believed to have been going on for seven months and has not yet come to a conclusion.

The investigation is believed to relate to alleged gambling activities during his time as a player in the lower leagues and before his move to Brentford.

It is believed there is no suggestion the Brentford striker ever bet on his own team to lose.

Toney, who was chosen in Gareth Southgate’s last England squad but has yet to make his debut, is said to be devastated by news of the investigation leaking.

Ivan Toney is being investigated by the FA over allegations of past gambling

He is desperate to play for his country and be part of Southgate’s World Cup squad, which will be named on Thursday.

He was proud to have been called up to the squads for recent Nations League fixtures and hopes news of the investigation will not jeopardize his chances.

Many consider Toney the ideal replacement for England captain Harry Kane, not only because of the form he has been in for Brentford, but also because he is a brilliant penalty taker who would be a major asset if England were implicated in World Cup shootings. Cup.

The 26-year-old striker says he is devastated by the leaked news of the investigation

The 26-year-old striker says he is devastated by the leaked news of the investigation

Toney is believed to be desperate to make Gareth Southgate's final 26-man World Cup squad

Toney is believed to be desperate to make Gareth Southgate’s final 26-man World Cup squad

Toney took to Twitter on Saturday to post a statement on the FA investigation

Toney took to Twitter on Saturday to post a statement on the FA investigation

Toney took to Twitter Saturday to issue a statement. He said: ‘I heard about a story about me in a national newspaper today. I have assisted the Football Association with their investigations and will not comment until that investigation is completed. I am a proud Englishman and it was always my childhood dream to play for my country in a World Cup final.

Brentford released a short statement Saturday regarding the investigation, which read: “We are noting the story regarding Ivan Toney and the FA investigation. The club will not comment.


FDA approves new indication for Vemlidy Wed, 02 Nov 2022 15:32:17 +0000

The United States Food and Drug Administration (FDA) has approved the Supplemental New Drug Application (sNDA) for Vemlidy (tenofovir alafenamide) 25 mg tablets as a once-daily treatment for chronic HIV infection. hepatitis B (HBV) in pediatric patients aged 12 years and elderly with compensated liver disease.

Developed and marketed by our leading biotechnology company Gilead Sciences (Nasdaq: GILD), Vemlidy has already obtained FDA approval for the treatment of adults with this…

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What Russia’s “Dirty Bomb” Nuclear Rhetoric Means Sun, 30 Oct 2022 21:00:36 +0000

Russian rhetoric on the use of nuclear weapons was full of seemingly mixed signals last week.

First, Defense Minister Sergei Shoigu called around its Western counterparts, claiming that Ukraine is preparing to use a radioactive “dirty bomb” – which is not a nuclear weapon per se, but which could possibly be used in a false flag attack like a pretext for Russian nuclear escalation. But then President Vladimir Putin Thursday offered a the assurance, after tactical nuclear exercises, that its army is not planning a nuclear attack against Ukraine.

It’s impossible to know what Putin really thinks – and how far he’s willing to go to justify his continued attack on Ukraine – but there’s a reason not to take this week’s message from Moscow as an indication that Russia is currently preparing a nuclear attack.

Experts told Vox the most likely explanation is that it is an attempt to pressure the West to force Ukraine to reach a peace agreement. The war goes badly for Russian forces and Europe faces a long, cold winter without Russian energy supplies. It is also an attempt to distort the information environment and sow confusion and misinformation – an integral part of Russian warfare doctrine.

Putin has warned throughout Russia’s seven-month war against Ukraine (and even before) that he would use nuclear weapons in response to perceived NATO and Western aggression. But Wednesday’s drills aren’t necessarily a sign he’s going all the way. The exercises, in fact, take place every year; The Russian defense apparatus followed protocol to alert the US Department of Defense about them, and NATO began conducting its own nuclear exercises on October 17.

The Russian account that Ukraine plans to use a dirty bomb has obvious similarities with its false claims that rebel groups have perpetrated chemical attacks in Syria. Although no Western official or expert finds the dirty bomb allegations credible, the Russians Chief of General Staff Valery Gerasimov on Monday, he contacted his American and British counterparts to express his concern. Shoigu called defense officials in the United States, United Kingdom, France and Turkey on Sunday with the same message, according to the Institute for the Study of War (ISW). Monday’s call was the first between Gerasimov and Chairman of the Joint Chiefs of Staff Gen. Mark Milley since May. That this happened is a positive development, Iindicating that communication channels between Russia and the West still exist, reducing the likelihood of escalation.

But it is also an indicator that Moscow is probably trying to poison the information space and sow doubt in the West about the risks of supporting Ukraine in its continued struggle for sovereignty, ISW senior intelligence analyst Katherine Lawlor told Vox.

“The fact that we’re having these conversations means it’s working,” she said.

Putin may be trying to step up, but not the way we think

As with many nuclear posturing, the purpose of Russia’s latest nuclear weapons moves may be less to actually use nuclear weapons than to exert pressure and sow fear and confusion.

This week’s nuclear exercises are not themselves unusual; they were planned and Russian defense officials alerted the US Department of Defense that they were continuing, as Moscow is required to do under its obligations as a signatory to the New START treaty. “In this regard, Russia is meeting its arms control obligations and transparency commitments to make these notifications, and so this is something we will continue to monitor,” the Pentagon spokesperson said. Air Force Gen. Pat Ryder said Tuesday.

The drills simulated a response to a potential attack and activated Russian air, land and sea defensesas Reuters reported on Thursday.

But it is important to keep in mind that such exercises are not only training maneuvers, they are also demonstrations of force, propaganda in a sense. That’s what prompted experts to watch this week’s drills, according to Natia Seskuria, a partner at the Royal United Services Institute.

“Now Russia is increasingly using nuclear threats to blackmail the West,” she told Vox via email. “Last time Russia held such drills just before launching the war in Ukraine,” so the drills could signal some form of escalation, but not necessarily in a nuclear sense.

“It seems that Putin is trying to exert additional pressure on the West and overshadow the fact that Russian conventional forces are not succeeding in Ukraine. The Kremlin hopes that by stepping up nuclear rhetoric, the West would be willing to try to convince Ukraine to negotiate and agree to concessions,” Seskuria said.

Putin had previously warned that he would be ready to use nuclear weapons during his invasion and annexation of Crimea in 2014, and Russian nuclear doctrine permits first use in response to conventional warfare – not necessarily solely in response to nuclear attack. According to an April report from Congressional Research Service, “This doctrine has led some US analysts to conclude that Russia has adopted an ‘escalation to defuse’ strategy.”

Although Ukraine is not a member of NATO (it has applied for membership), it enjoys the support of the United States and other NATO allies, which have weapons provided and training of Ukrainian troops to great effect. But throughout the war, NATO members were careful to avoid the possibility or appearance of a direct conflict with Russia or a strike on Russian territory — a line that could be increasingly difficult to navigate given Putin’s annexation of four southern Ukrainian regions earlier this month.

Dirty bomb rhetoric is also an old tactic – this is similar to Russian claims in Syria that rebel groups, the White Helmets relief groupeven if these groups did not have access to chemical weapons and the Syrian regime, backed by Russia, was actually carrying out the attacks. Kremlin-aligned Twitter accounts and media then repeatedly amplified Russia’s claims.

Now, “Russian state media has been spreading the ‘dirty bomb’ accusations and spreading fear,” Seskuria told Vox. “Russian media have a large part in mobilizing public opinion and are part of the Kremlin’s war propaganda machine,” she said, adding that “the ‘dirty bomb’ accusations [are] also intended for domestic consumption, in conjunction with a high probability that Russia is planning a false flag operation.

What will happen next?

Cheese fries said Thursday that Russia would not strike Ukraine with nuclear weapons, despite its previous threatening rhetoric.

“It makes no political or military sense,” Putin said, saying statements about using all means at his disposal to protect Russia were in response to Western threats.

While Putin’s threats to use tactical nuclear weapons should be taken seriously, there are also a number of preparatory steps that would occur before these weapons are actually used on the battlefield. “I think we would see additional steps on the climbing ladder before we had [to a nuclear attack]“, like a weapons test on the surface, Lawlor said. such as Secretary of State Antony Blinken have indicated they take the possibility of an escalation seriously, the evidence so far does not point to the imminent use of tactical nuclear weapons on the battlefield.

Moreover, such weapons would probably not be very useful for Russia, given their rather limited usefulness on the front line and the inability of Russian conscripts to actually fight in this landscape. “From an operational point of view, I don’t think the Russian forces are ready to fight in a nuclear environment, because the ‘correct’ use of nuclear weapons […] would basically be used to punch holes in Ukrainian lines,” Lawlor said, allowing Russian mechanized units to cross and attack Ukrainian units from behind.

Given what we have seen of Russian troops so far, the likelihood of them successfully executing these plans is not high. “Even the units that are trained for this are so degraded at this point,” Lawlor said. “And you’re going to tell me that a guy who was a policeman in Krasnodar Krai three weeks ago and who was forcibly mobilized in the street is going to charge into an irradiated area? Absolutely not.”

It is not entirely clear that the use of nuclear weapons on the battlefield would achieve Putin’s immediate objective of preventing Ukrainian forces from advancing further and allowing Russian forces to advance, given how devastating a NATO response to tactical nuclear weapons could be, Lawlor told Vox. “The operational effects of NATO retaliation in Ukraine – which would likely include the targeting of Russian forces, probably not troop concentrations but command posts, logistics, things like that – will devastate its operational ability to continue. to advance along the front line.”

Nuclear weapons and bogus dirty bomb scares don’t make much logistical sense, and they’re not new.

That doesn’t mean the West can ignore Putin’s nuclear posture — the risk is too great, as Ankit Panda, Stanton’s senior fellow at the Carnegie Endowment for International Peace, has put it. The New Yorker Isaac Chotiner earlier this month. “Hopefully it’s somewhere we don’t have to go, but, of course, governments are planning for all sorts of eventualities, and those conversations have been behind closed doors for the past few months as the prospect of a nuclear escalation lingered,” he said. To this end, the United States also sent private communications to Moscow warning against the use of nuclear weapons, the Washington Post reported in September.

But to sow discord, confusion and misinformation in the information space is a known and tested part of Russian asymmetric warfare doctrine, which Ukraine and partner countries deliberately fought against before and at the beginning of the war. Don’t expect him to let up anytime soon.

BOJ meeting Friday October 28 preview – ‘no strong indication that change is imminent’ Thu, 27 Oct 2022 22:10:00 +0000

Extract on the Bank of Japan meeting and the outlook for the yen.

It’s via the folks at eFX.

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Credit Suisse maintains a bullish bias on USD/JPY over the next few weeks.

  • “We said we weren’t inclined to fade on USDJPY strength, even though the pair is trading near our 150 target. A week later, and with quite aggressive FX intervention and a significant rally in US Treasuries in the rearview mirror, the JPY is trading less than 1% higher from the levels prevailing at the time.With no visibility on the outcome of the BOJ’s decision of this week and with no strong indications that a change is imminent beyond a shift in market expectations, we still don’t see a strong urge to take a different approach at this time,” CS notes.
  • “In the event that the BOJ does signal a change in forward guidance, a further drop down from our Q4 140 – 150 target range is possible, but far from certain, given the backdrop of already fairly high market expectations. We are also skeptical that a minor change in forward guidance would trigger a deeper or longer lasting correction, given our optimistic view of Fed tightening and the still limited prospect of a change. major shift in actual BOJ policy before the end of Governor Kuroda’s tenure in April 2023,” CS adds.
Pantheon Resources PLC says Alaska well shows ‘promising indications’ of reservoir performance Tue, 25 Oct 2022 07:26:52 +0000

Pantheon Resources PLC (AIM:PANR, OTC:PTHRF) told investors that the Alkaid-2 well in Alaska has shown promising indications of reservoir performance as it remains in the early stage of cleanup, ahead of production testing.

Oil was produced from the well with a strong backflow of frac fluid – measured in thousands of barrels of fluid per day – including frac sand which was described by Pantheon as higher than expected but not uncommon.

So far, the company has recovered approximately 10% of the fracturing fluid that has been injected into the well, and in the recovered fluid, it has seen an oil reduction of between 8% and 12%.

“Often the first real indications of oil come much later,” chief executive Jay Cheatham said in a statement. “While frac sand production is impractical, as is the wait time to obtain a coiled tubing unit, it is not an uncommon occurrence in multi-stage fracture stimulation completions in reservoirs. conventional and will be processed once the unit arrives.”

Cheatham added: “It is encouraging that the reservoir response to the stimulation procedure was very good, as we experienced strong initial fluid flows measured in the thousands of barrels per day.

“These are conventional reservoirs that have superior reservoir qualities compared to shales, and given that this is our first well completion applying stimulation techniques in these reservoirs, it requires some patience as we better understand the characteristics of our reservoirs on the North Slope.”

The well is now closed as planned, as part of a transition process from temporary flowback facilities to larger permanent facilities, and a coiled tubing unit will be used to clean out the wellbore. Other preparations for production testing will also be undertaken, including pressure build-up methods.

Pantheon noted that generally “better indications” of actual performance can be determined after more than 40% of the fracturing fluid has been recovered. He expects to reach that point “over the next few weeks.”

Michael Duncan, Vice President of Operations and Engineering at Pantheon, meanwhile called the early results so far “very encouraging” and highlighted the operational progress.

“Before going into initial production, it’s common to clean out a wellbore,” he said. “We use a planned outage for the connection of our permanent installations in order to carry out a pressure build-up of the well as well as the cleaning of the borehole.

“The operating season has been good so far and we look forward to having a fully operational system soon. Frac sand production is a nuisance that cost us time during the early stages of flowback, but is not believed to alter the well potential.”

FDA approves upadacitinib for non-radiographic active axial spondylitis Sat, 22 Oct 2022 03:09:33 +0000

The U.S. Food and Drug Administration (FDA) has approved upadacitinib (RINVOQ) 15 mg orally once daily for the treatment of adults with difficult-to-treat conditions. non-radiographic active axial spondyloarthritis (nr-axSpA).

The indication granted to AbbVie makes the JAK inhibitor the first in its class of drugs approved for both nr-axSpA and active ankylosing spondylitis (AS), and marks its sixth FDA indication in inflammatory diseases.

As a selective JAK inhibitor, upadacitinib has been shown to positively treat and is indicated for rheumatoid arthritis, psoriatic arthritis, AS, and active ulcerative colitis. It is also being considered for the treatment of chronic immune-mediated inflammatory diseases, including plaque psoriasis and Crohn’s disease.

The latest FDA approval for upadacitinib was supported by results from the pivotal Phase 3 SELECT-AXIS 2 clinical study, in which the daily oral agent evaluated efficacy, safety and tolerability in adults with active nr-axSpA.

Investigators in the randomized, placebo-controlled, double-blind trial compared upadacitinib to placebo on outcomes, including reduction in some components of the composite AS Disease Activity Score (ASAS), a scale with infinite items rating disease activity from zero (0) at any level of disease severity. Components observed from the index included patient total low back pain, patient global assessment (PGA) of disease activity, morning stiffness, and physical function. The team measured the ASAS40 response as improvement in disease activity in patients by ≥40% from baseline.

The investigators also looked for multiplicity-controlled endpoints, including total back pain and the Bath Ankylosing Spondylitis Disease Activity Index (BASFI).

At 14 weeks, the team observed a significantly greater mean decrease in total back pain from baseline in those treated with upadacitinib compared to placebo, as well as a significantly greater improvement in physical function according to the BASFI.

Almost half of all patients in the upadacitinib arm achieved an ASAS40 response at week 14 (44.9%), compared to only 22.3% in the placebo arm.

Researchers observed a similar safety profile for upadacitinib in SELECT-AXIS 2, as seen in clinical trials evaluating patients with rheumatoid arthritis, psoriatic arthritis and AS.

In a statement accompanying the approval, principal investigator Atul Deodhar, MD, professor of medicine and medical director of rheumatology clinics for the division of arthritis and rheumatic diseases at Oregon Health & Science University, called the new indication from the FDA for JAK inhibitors offers “an important new treatment option for patients and their caregivers to help control their symptoms and disease.”

“Many patients living with nr-axSpA continue to experience symptoms and are unable to control the disease with current treatments,” Deodhar said. “In the SELECT-AXIS 2 trials, RINVOQ demonstrated efficacy in both nr-axSpA and AS with consistent safety across all indications.”