EPIDYOLEX® receives marketing authorisation in Europe
Posted: 23 September 2019 | Victoria Rees (European Pharmaceutical Review) | No comments yet
The cannabidiol-based treatment EPIDYOLEX has been granted marketing authorisation from the European Commission.
The European Commission (EC) has granted marketing authorisation for EPIDYOLEX®, a medication made using highly purified cannabidiol (CBD).
The approval of EPIDYOLEX marks… the first and only EMA-approved CBD medicine”
The drug is intended for use as an adjunctive therapy for seizures associated with Lennox‑Gastaut syndrome (LGS) or Dravet syndrome, in conjunction with clobazam, for patients two years of age and older.
Manufactured by GW Pharmaceuticals, EPIDYOLEX received a positive opinion for the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in July. It was also approved by the US Food and Drug Administration (FDA) in June 2018.
The decision for the CBD oral solution is based on four randomised, controlled Phase III trials.
“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,” said Justin Gover, GW’s Chief Executive Officer.
Biopharmaceuticals, Cannabinoids, Clinical Development, Regulation & Legislation