GW Pharmaceuticals announced that the European Commission (EC) has authorized the marketing and advertising authorization for EPIDYOLEX®, a synthetic type of cannabidiol (CBD), for use as adjunctive therapy of seizures linked with Lennox‑Gastaut syndrome (LGS) or Dravet syndrome, in conjunction with clobazam, for sufferers two years of age and older. The approval paves the way for the launch of the medicine across Europe.
“The approval of EPIDYOLEX® marks a substantial milestone, supplying sufferers and their households the initially in a new class of epilepsy medicines and the initially and only EMA-authorized CBD medicine to treat two extreme and life-threatening types of childhood-onset epilepsy,” mentioned Justin Gover, GW’s Chief Executive Officer.
When added to other anti-epileptic therapies, EPIDYOLEX® significantly decreased the frequency of seizures in sufferers with LGS and Dravet syndrome. The most frequent adverse reactions that occurred in sufferers treated with the medicine have been somnolence, decreased appetite, diarrhoea, pyrexia, fatigue and vomiting. GW’s improvement programme represents the only effectively-controlled clinical evaluation of a cannabinoid medication for sufferers with LGS and Dravet syndrome.
“LGS and Dravet syndrome are two of the most extreme and complicated-to-treat types of childhood-onset epilepsy, with couple of sufferers reaching sufficient seizure manage,” mentioned Professor Elinor Ben-Menachem, University of Goteborg, Sahlgren Academy and Hospital in Sweden. “The EMA approval of EPIDYOLEX® will bring hope to sufferers and households, with the prospective to superior manage seizures and increase high quality of life.”
The EC choice is valid in all 28 nations of the European Union, alongside Norway, Iceland and Liechtenstein.
GW’s cannabidiol oral answer was authorized by the U.S. Meals and Drug Administration (FDA) in June 2018 beneath the trade name EPIDIOLEX® for the therapy of seizures linked with LGS or Dravet syndrome in sufferers two years of age or older.