Approval paves the way for launch across Europe.
“We are very happy that patients will now have access to a much-needed, new treatment option, and one routed through a rigorous clinical trials programme and licensed by the EMA.”
GW Pharmaceuticals has received European Commission approval for the marketing authorisation for EPIDYOLEX® for use as adjunctive therapy of seizures associated with Lennox‑Gastaut syndrome (LGS) or Dravet syndrome, in conjunction with clobazam, for patients 2 years of age and older.
The approval of EPIDYOLEX® marks a significant milestone, offering patients and their families the first in a new class of epilepsy medicines and the first and only EMA-approved CBD medicine to treat two severe and life-threatening forms of childhood-onset epilepsy.”Justin Gover, GW’s CEO
“This approval is the culmination of many years of dedication and collaboration between GW, physicians and the epilepsy community,” he said.
APPROVAL BASED ON FOUR PHASE III CLINICAL TRIALS
The studies incorporate data from more than 714 patients with either LGS or Dravet syndrome, two rare forms of epilepsy with high morbidity and mortality rates.
Many of these patients have multiple seizures per day. Despite current anti-epileptic drug treatment, both of these severe forms of epilepsy remain highly treatment-resistant.
“We are very happy that patients will now have access to a much-needed, new treatment option, and one routed through a rigorous clinical trials programme and licensed by the EMA.”Isabella Brambilla, Chair, Dravet Syndrome European Federation.
“The EMA approval of EPIDYOLEX® will bring hope to patients and families, with the potential to better control seizures and improve quality of life,”she said.
When added to other anti-epileptic therapies, EPIDYOLEX® significantly reduced the frequency of seizures in patients with LGS and Dravet syndrome.
The most common adverse reactions were somnolence, decreased appetite, diarrhoea, pyrexia, fatigue and vomiting.
GW’s development programme represents the only well-controlled clinical evaluation of a cannabinoid medication for patients with LGS and Dravet syndrome.
GW’s cannabidiol oral solution was approved by the U.S. Food and Drug Administration (FDA) in June 2018 under the trade name EPIDIOLEX® for the treatment of seizures associated with LGS or Dravet syndrome in patients two years of age or older.
The EC decision is valid in all 28 countries of the European Union, alongside Norway, Iceland and Liechtenstein.