GW Pharmaceuticals plc (NASDAQ:GWPH), the medicinal cannabis giant, has received European Commission (EC) approval for the treatment of seizures associated with tuberous sclerosis complex.
The EC has approved the Type II variation application for GW’s EPIDYOLEX (cannabidiol) as an adjunctive treatment of seizures for patients two years old or older.
The approval paves the way for the expanded launch of the medicine across Europe.
“This approval is the result of the continued dedication of GW and the physician and patient communities to address this serious unmet medical need,” said Justin Gover, GW’s chief executive officer. “
“We now look forward to working with each European member state to make EPIDYOLEX available to appropriate patients across Europe, as quickly as possible,” he added.
GW’s cannabidiol was originally approved by the European Medicines Agency (EMA) in September 2019 under the tradename EPIDYOLEX as an adjunctive therapy for seizures associated with Lennox-Gastaut Syndrome or Dravet syndrome, in conjunction with clobazam.
It is also the first prescription, plant-derived cannabis-based medicine approved by the US Food and Drug Administration for use in the US and the European Commission for use in Europe.
Tuberous sclerosis complex is a rare genetic condition that has an estimated prevalence in the EU of 10 in 100,000, GW said.