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
Click here to read full press release/ article | Ref: Jazz Pharmaceuticals | Image: GW Pharma
The post GW’s Epidyolex (cannabidiol) Receives MHRA’s Approval for the Treatment of Seizures Associated with Tuberous Sclerosis Complex in UK first appeared on PharmaShots.
