“While we are disappointed with today’s outcome, we believe the scientific evidence supports the approval of roxadustat in the United States and will work with the FDA as it completes its review of the new drug application for the roxadustat, ”said Enrique Conterno, Managing Director of FibroGen. in a report.
Roxadustat is a hypoxia-inducible factor prolyl hydroxylase (HIF-PHI) inhibitor to be marketed for the treatment of anemia in patients with CRF. HIF-PHI drugs aim to restore the production of the hormone erythropoietin and improve iron regulation; currently the disease is treated with epoetin alpha and darbepoetin alpha injections.
This app has had an eventful journey. Fibrogen submitted the new drug application for roxadustat tablets in December 2019 for the treatment of anemia associated with CRF in both dialysis and non-dialysis patients. The PDUFA date was March 20, 2021, which was already an extension of the original PDUFA date of December 20, 2020. This time, agency officials called for the establishment of an advisory committee to review the decision. NDA.
According to FDA documents ahead of the meeting, agency officials believed the data showed roxadustat to be effective. The concern, an agency official said, was overcorrection of hemoglobin, especially in patients not dependent on dialysis. Although the data submitted has demonstrated its effectiveness in increasing hemoglobin levels, roxadustat tends to exceed targets in patients who are not dependent on dialysis.
Darzalex Faspro receives another indication. FDA Approved Darzalex Faspro by Janssen (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior line of treatment.
The approval follows regulatory submission to the FDA in November 2020 and marks the sixth indication for Darzalex Faspro in the treatment of multiple myeloma. The approval is based on the results of the phase 3 APOLLO study. The results of this study were presented at the 2020 American Society of Hematology (ASH) Annual Meeting and were published in June 2021 in The Lancet Oncology. Researchers found that Darzalex Faspro reduced the risk of progression or death by 37%, compared to pomalidomide and dexamethasone. The most common serious side effects were pneumonia (15%) and lower respiratory tract infections (12%). Fatal side effects occurred in 7% of patients.
Bayer obtains Kerendia approval. FDA Approved a first-class nonsteroidal mineralocorticoid receptor antagonist (MRA) to treat chronic kidney disease in patients with type 2 diabetes. Kerendia (finerenone) is approved to reduce the risk of sustained drop in eGFR, kidney failure, cardiovascular death, non-fatal myocardial infarction and hospitalization for heart failure in adult patients with chronic kidney disease associated with type 2 diabetes.
Kerendia’s approval is based on the positive results of the pivotal Phase 3 FIDELIO-DKD study, presented at the American Society of Nephrology (ASN) Kidney Week Reimagined 2020 and simultaneously published in the New England Journal of Medicine in October 2020, and follows the priority review designation granted by the FDA in January 2021.
FDA grants full approval for Rezurock. Kadmon Holdings has ad that the FDA has approved Rezurock (belumosudil) for the treatment of adult and pediatric patients 12 years of age and older with chronic graft-versus-host disease (cGVHD) after the failure of at least two prior lines of treatment systemic.
Rezurock is expected to be available in late August 2021. It is the first FDA-approved small molecule inhibitor of ROCK2, a signaling pathway that modulates inflammatory responses and fibrotic processes.
Approval is based on the safety and efficacy results of ROCKstar (KD025-213), a multicenter, randomized, open-label pivotal trial of Rezurock in 65 patients with cGVHD who had received two to five prior lines of systemic therapy. . Therapy achieved an overall response rate of 75% through the first day of the treatment cycle, 6% of patients achieved a complete response and 69% achieved a partial response. Sixty-two percent (62%) of responders did not require new systemic therapy for at least 12 months after response.
Two JAK inhibitors are missing PDUFA dates. Early Friday morning, two companies with Supplemental New Drug Applications (sNDAs) pending FDA decisions on JAK inhibitors to treat atopic dermatitis announced the agency would miss their PDUFA dates. AbbVie ad its update on the sNDA for Rinvoq (upadacitinib) for the treatment of adults and adolescents with moderate to severe atopic dermatitis.
Rinvoq is an inhibitor of JAK which is being studied in several immune-mediated inflammatory diseases. In August 2019, the treatment received FDA approval for adult patients with moderately to severely active rheumatoid arthritis who had an inadequate response to or intolerance to methotrexate.
Eli Lilly and company and Incyte ad the missed PDUFA date sNDA for Olumiant (baricitinib) for the treatment of adults with moderate to severe atopic dermatitis (AD). Olumiant, an oral JAK inhibitor discovered by Incyte and licensed to Lilly, is approved for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) in more than 75 countries. It is also approved in over 40 countries for the treatment of adults with moderate to severe AD who are candidates for systemic treatment.
In June, AbbVie also had ad that the sNDA for Rinvoq to treat psoriatic arthritis and ankylosing spondylitis would also miss its PDUFA date.
The delays in these applications appear to be part of the ongoing FDA evaluation of JAK inhibitors. In January, Pfizer published results of ORAL surveillance, its postmarketing cardiovascular safety trial of Xeljanz (tofacitinib) in patients with rheumatoid arthritis.
This study compared Xeljanz with a TNF inhibitor and included 4,362 subjects who received study treatments. The main analyzes included 135 subjects with major adverse cardiovascular events (MACE) and 164 subjects with malignant tumors (excluding non-melanoma skin cancer). For tofacitinib, the most frequently reported MACE was myocardial infarction and the most frequently reported cancer (excluding NMSC) was lung cancer. In subjects with a higher prevalence of known risk factors for MACE and malignancy (eg, advanced age, smoking), a higher frequency of events was observed in all treatment groups.
Both AbbVie and Lilly officials say they are confident in the data for their indications of atopic dermatitis.