International
Epidyolex approved by the European Medicines Agency
GW Pharmaceuticals announced on 23 September the Marketing Authorization (MA) approval of its anti-epileptic drug Epidyolex (Epidiolex in the United States) by the European Medicines Agency (EMA) as an orphan drug (drugs used in rare diseases) .
Epidiolex (cannabidiol oral solution) is the first cannabinoid-based drug (in this case CBD – cannabidiol), of plant origin, to have its AIM approved by the European Medicines Agency (EMA). In July 2019, the EMA's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on the drug, where it recommended deferring the MA application for this indication.
According to official document of the EMA, Epidyolex is used to treat seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients aged two years and over, together with Clobazam, in addition to the treatment of tuberous sclerosis . The EMA's approval was based on data from four phase III studies, which evaluated Epidiolex in 714 patients with LGS or Dravet syndrome. When added to other anti-epileptic therapies, Epidyolex significantly reduced seizure frequency in the patient population in question.
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[Disclaimer: Please note that this text was originally written in Portuguese and is translated into English and other languages using an automatic translator. Some words may differ from the original and typos or errors may occur in other languages.]____________________________________________________________________________________________________
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I am one of the directors of CannaReporter, which I founded together with Laura Ramos. I am from the unique Island of Madeira, where I currently reside. While I was in Lisbon at FCUL studying Physical Engineering, I became involved in the national hemp and cannabis scene and participated in several associations, some of which I am still a member of. I follow the global industry and especially legislative advances regarding the different uses of cannabis.
I can be contacted by email at joao.costa@cannareporter.eu
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