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GW's Epidyolex (cannabidiol) Receives MHRA's Approval for the Treatment of Seizures Associated with Tuberous Sclerosis Complex in UK

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GW's Epidyolex (cannabidiol) Receives MHRA's Approval for the Treatment of Seizures Associated with Tuberous Sclerosis Complex in UK

GW's Epidyolex (cannabidiol) Receives MHRA's Approval for the Treatment of Seizures Associated with Tuberous Sclerosis Complex in UK

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

Click here to­ read the full press release 

Tuba

Tuba was Senior Editor at PharmaShots. She was curious, creative, and passionate about recent updates and innovations in the life sciences industry. She covered Biopharma, MedTech, and Digital health segments. Tuba also had an experience in digital and social media marketing and ran the campaigns independently. She can be contacted at connect@pharmashots.com.

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