Shots:

• The approval is based on P-III study evaluating cannabidiol (25 mg/kg/day) vs PBO in patients aged ≥2yrs. as an adjunctive treatment of seizures associated with TSC
• The study met its 1EPs i.e reduction in seizure frequency (49% vs 27%). The 2EPs supports the effects on 1EPs and safety profile was consistent with findings from previous studies with no new safety risks were identified
• The EC has approved the Type II variation application for Epidyolex and marks the third indication in EU with the expanded launch across Europe. The EC decision is valid in all 27 countries

  Ref: Business Wire | Image: Benzinga