GW Pharmaceuticals announced that the European Commission (EC) has authorized the promoting authorization for EPIDYOLEX®, a synthetic type of cannabidiol (CBD), for use as adjunctive therapy of seizures connected 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, providing sufferers and their households the initial in a new class of epilepsy medicines and the initial and only EMA-authorized CBD medicine to treat two serious 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 lowered the frequency of seizures in sufferers with LGS and Dravet syndrome. The most prevalent adverse reactions that occurred in sufferers treated with the medicine had 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 serious and tough-to-treat types of childhood-onset epilepsy, with couple of sufferers attaining sufficient seizure handle,” 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 possible to superior handle seizures and strengthen high-quality of life.”
The EC selection is valid in all 28 nations of the European Union, alongside Norway, Iceland and Liechtenstein.
GW’s cannabidiol oral resolution was authorized by the U.S. Meals and Drug Administration (FDA) in June 2018 beneath the trade name EPIDIOLEX® for the therapy of seizures connected with LGS or Dravet syndrome in sufferers two years of age or older.