Shots:

• The approval is based on P-III safety & efficacy study that evaluates Epidyolex (25 mg/kg/day) vs PBO in patients aged ≥2yrs. as an adjunctive treatment with seizures associated with TSC
• The study met its 1EPs i.e.- reduction in seizure frequency (49% vs 27%). The 2EPs had supported the effects on 1EPs & safety profile was consistent with previous studies results with no new safety risks observed
• Epidyolex will be available in England- Wales- and Scotland & follows the recent approval in all 27 countries of the EU along with Norway- Iceland & Liechtenstein. The approval marks the 4th indication of the drug in the UK & the therapy received EMA’s ODD for seizures associated with LGS- Dravet syndrome & TSC

  | Ref: Jazz Pharmaceuticals | Image: GW Pharma