GW Prescription drugs introduced that the Committee for Medicinal Merchandise for Human Use (CHMP) really helpful approval of the British firm’s cannabis-based medication Epidiolex.
The CHMP is answerable for making ready the European Medicines Company (EMA)’s opinions on questions associated to the advertising of human medicines.
The CHMP opinion was adopted July 25, and the ultimate determination now rests with the European Fee, which GW Pharma expects in about two months.
Epidiolex was really helpful “to be used as adjunctive remedy of seizures” linked to Lennox-Gastaut syndrome or Dravet syndrome, along side the sedative Clobazam, for sufferers a minimum of 2 years previous.
The CHMP primarily based its advice on the outcomes from 4 randomized, managed Section three trials.
In June 2018, the U.S. Meals and Drug Administration gave approval to a GW Prescription drugs CBD oral resolution, marketed as Epidiolex, for the remedy of the identical situations.
That is the primary time a plant-derived cannabis medication obtained a constructive opinion within the EU’s centralized process for approving medicines.
Sativex, one other GW Pharma product, is obtainable in a number of European nations however not all throughout Europe. In Germany, it has an virtually 20% market share inside the insurance-covered medical cannabis gross sales.
GW Pharma grows its personal provide of cannabis in the UK and trades on the Nasdaq beneath the ticker image GWPH.