GW Pharmaceuticals plc GWPH announced that the European Commission (EC) has approved its anti- epileptic drug Epidyolex as an adjunct treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in conjunction with clobazam for patients aged two years or older.
The nod makes Epidyolex (cannabidiol oral solution) the first plant-derived cannabinoid prescription medicine to be approved by the European Medicines Agency (EMA). The drug is also the first and the only EMA-approved cannabidiol (CBD) medicine approved to treat LGS and Dravet syndrome, two severe and life-threatening forms of childhood-onset epilepsy.
In July 2019, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion on Epidyolex, recommending its marketing authorization application for the given indication.
Epidyolex is marketed as Epidiolex in the United States for treating seizures associated with LGS or Dravet syndrome in patients aged two years and above.
The EU approval was based on data from four phase III studies, which evaluated Epidyolex in 714 patients with either LGS or Dravet syndrome. When added to other anti-epileptic therapies, Epidyolex significantly reduced the frequency of seizures in the given patient population.
Shares of GW Pharmaceuticals have rallied 29.9% so far this year compared the industry’s increase of 17.4%.
Epidiolex was approved in the United States in June 2018. The product became the first cannabis-derived medicine to gain an approval from the FDA for the treatment of LGS and Dravet syndrome in patients aged two years or older.
Epidiolex generated sales of $101.9 million in the first half of 2019. The drug has seen a strong uptake in sales and new patient enrollments since its launch.
In May this year, GW Pharmaceuticals announced positive top-line results from the phase III study evaluating Epidiolex for treating seizures associated with tuberous sclerosis complex (TSC). A supplemental new drug application for the same is expected to be filed in the fourth quarter of 2019.
We remind investors that the marijuana industry has a solid potential, especially after its legalization for recreational and medicinal use. Further, legalization of cannabis is likely to drive its commercial distribution and boost growth of companies operating in this space. Apart from GW Pharmaceuticals, companies, such as CannTrust Holdings Inc. CTST, Cronos Group Inc. CRON and Canopy Growth Corp. CGC are all discovering, developing and manufacturing drugs from cannabis for various recreational and medicinal purposes.
GW Pharmaceuticals currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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