JAZZ - GW Pharma get European nod on expanded label for Epidyolex

GW Pharmaceuticals (GWPH) announced that the European Medicines Agency has issued a positive opinion on its Type II variation application for EPIDYOLEX® (cannabidiol) as an adjunctive treatment of seizures associated with Tuberous Sclerosis Complex.The decision by the EMA’s Committee for Medicinal Products for Human Use was based on a positive Phase 3 safety and efficacy study that evaluated 25 mg/kg/day of GW’s cannabidiol (oral solution) against placebo.In 2019, the EU approved Epidyolex as adjunctive therapy in combination with clobazam for seizures associated with Lennox-Gastaut Syndrome (“LGS”) or Dravet syndrome.Early this month, Jazz Pharmaceuticals ([[JAZZ]] -0.7%) announced an agreement to acquire GW Pharmaceuticals in a deal worth $7.2B.

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GW Pharma get European nod on expanded label for Epidyolex