GW Pharmaceuticals Receives Reimbursement Approval For Epidyolex® (Cannabidiol) For Treatment Of Seizures Associated With Tuberous Sclerosis In Wales


GW Pharmaceuticals Gets Approval for Reimbursement of Epidyolex® (cannabidiol) for the treatment of seizures associated with tuberous sclerosis in Bourneville in Wales

Wales becomes first UK country to fund Epidyolex® (cannabidiol) for tuberous sclerosis Bourneville (TSS)

TSC causes epilepsy in up to 85% of patients, and up to 60% of these patients do not respond to standard anti-seizure drugs1,2,3

DUBLIN, December 15, 2021 – Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced Epidyolex® (cannabidiol), developed by GW Pharmaceuticals (“GW”), a global leader in the discovery, development and delivery of regulatory approved cannabis medicines, has been recommended by the All Wales Medicines Strategy Group (AWMSG) for use within NHS Wales for the treatment of seizures associated with Tuberous Sclerosis (TSS), in patients two years of age and older.

The move makes Wales the first country in the UK to make GW cannabidiol available for routine TSC reimbursement. Having already received reimbursement for Lennox-Gastaut syndrome (LGS) and Dravet syndrome, this decision means that the three conditions for which Epidyolex is made redundant are now reimbursed in Wales.

It follows the authorization of GW’s cannabidiol by the UK Medicines and Health Products Regulatory Agency (MHRA) for use as an add-on treatment for seizures associated with TSC, for patients aged two years and more in August 2021.

“This is an extremely important decision for patients, their families and clinicians in Wales, where additional treatment options are needed for people with this difficult-to-treat disease. We are delighted that the AWMSG has recommended the use of rigorously tested, proven and regulated cannabis-based drugs for seizures associated with TSC; the first country in the United Kingdom to recommend use in the three authorized indications of the medicine ”, said Chris Tovey, Executive Vice President, COO and General Manager, Europe and International at Jazz Pharmaceuticals. “This decision demonstrates that cannabis-based medicines can go through large, randomized, placebo-controlled trials and rigorous evaluation by the AWMSG to reach patients with significant unmet needs.”

Louise Fish, CEO of the Tuberous Sclerosis Association, said: “We are delighted with this decision in Wales to reimburse Epidyolex for tuberous sclerosis of Bourneville. Between 3,700 and 11,000 people in the UK, including Wales, are living with TSC, and eight in ten people living with TSC have epilepsy. To date, TSC-related epilepsy has often been difficult to manage with conventional epilepsy medications, and therefore new treatment options are desperately needed. We hope that other parts of the UK will follow Wales’ lead and make this new option available to patients who may benefit from this treatment.

ADDITIONAL INFORMATION

About GW Pharmaceuticals

GW Pharmaceuticals (GW), a subsidiary of Jazz Pharmaceuticals plc, has established a world leading position in cannabinoid science and medicine. Founded over two decades ago in response to significant unmet patient needs, patients remain our primary goal and improving their quality of life our motivation. GW’s pioneering work led to the regulatory approval of life-changing cannabis-based drugs, a world first. Our continued dedication has made it possible to treat thousands of patients with our drugs around the world. In 2021, GW received the Queens Award for Enterprise in Innovation in recognition of its innovative and groundbreaking work in cannabinoid science and drugs. GW was acquired by Jazz Pharmaceuticals in May 2021.

About Jazz Pharmaceuticals plc

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company dedicated to innovating to transform the lives of patients and their families. We are committed to developing drugs that change the lives of people with serious illnesses, often with limited or no treatment options. We have a diverse portfolio of commercialized drugs and new product candidates, from early to late stage development, in neuroscience and oncology. In these therapeutic areas, we are identifying new options for patients by actively exploring small molecules and biologics, and through innovative delivery technologies and cannabinoid science. Jazz is headquartered in Dublin, Ireland, and has employees around the world, serving patients in nearly 75 countries. For more information, please visit www.jazzpharma.com and follow @JazzPharma on Twitter.

About Epidiolex®/ Epidyolex® (cannabidiol)

Epidiolex®/ Epidyolex® (cannabidiol), the first plant-derived cannabis prescription drug approved by the United States Food and Drug Administration (FDA) for use in the United States and the European Commission (EC) for use in the United States. Union, is an oral solution that contains highly purified cannabidiol (CBD). In the United States, cannabidiol is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, or Bourneville tuberous sclerosis (TSC) in patients one year of age and older. Cannabidiol has been approved in the European Union under the trade name Epidyolex for adjuvant use in combination with clobazam to treat seizures associated with LGS and Dravet syndrome in patients two years of age and older, and for a adjuvant use to treat seizures associated with TSC, in patients two years of age and older. cannabidiol has received orphan drug designation from the European Medicines Agency (EMA) for the treatment of seizures associated with LGS, Dravet syndrome and TSC.

About Bourneville Tuberous Sclerosis Complex (TSS)

Bourneville tuberous sclerosis (SCT) is a rare genetic disease with an estimated prevalence in Europe of 10 in 100,000.6 The disease causes predominantly benign tumors to grow in vital body organs, including the brain, skin, heart, eyes, kidneys, and lungs, and is a leading cause of genetic epilepsy.4.6 The onset of epilepsy in TSC often occurs during the first year of life in patients initially with predominantly focal seizures or infantile spasms. It is associated with an increased risk of autism and intellectual disability.5 The severity of the disease can vary widely. In some children, the disease is very mild, while others can present with life-threatening complications.7.8

1. Nabbout R, Belousova E, Benedik MP, et al. Epilepsy in Tuberous Sclerosis Bourneville: Results from the TOSCA Study. Open epilepsy. March 2019; 4 (1): 73-84.

2. Boston Children’s Hospital. https://www.childrenshospital.org/conditions-and-treatments/conditions/t/tuberous-sclerosis-tsc/symptoms-and-causes. Accessed March 2021.

3. Chu-Shore CJ, Major P, Camposano S, Muzykewicz D, Thiele EA. The natural history of epilepsy in tuberous sclerosis Bourneville. Epilepsy 2010; 51 (7): 1236-41.

4. NIH Tuberous Sclerosis Fact Sheet. https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Tuberous-Sclerosis-Fact-Sheet.

5. Bourneville Tuberous Sclerosis Association website. https://tuberous-sclerosis.org/information-and-support/what-is-tsc/. Accessed August 2021

6. Prevalence and incidence of rare diseases: Bibliographical data. https://www.orpha.net/orphacom/cahiers/docs/GB/Prevalence_of_rare_diseases_by_alphabetical_list.pdf

7. TS Alliance website. https://www.tsalliance.org/. Accessed August 2021

8. de Vries PJ, Belousova E, Benedik MP, et al. Neuropsychiatric Disorders Associated with TSC (TAND): Findings from the TOSCA Natural History Study. Orphanet J Rare Dis. 2018; 13 (1): 157.

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