UCB’s Fintepla (fenfluramine) Receive EU Approval for Adjunctive Treatment of Seizures Associated with Lennox-Gastaut Syndrome
Shots:
- Fintepla has been approved in the EU for seizures associated with LGS as an add-on therapy to other anti-epileptic medicines in patients aged ≥2yrs.
- The approval was based on safety & efficacy data from a P-III clinical trial evaluating Fintepla vs PBO in 263 patients which showed a greater reduction in the frequency of drop seizures at a dose of 0.7mg/kg/day while no cases of valvular heart disease or pulmonary arterial hypertension were reported
- Fenfluramine is a serotonin-releasing agent that stimulates multiple 5-HT receptor sub-types through the release of serotonin. To ensure consistent cardiac monitoring & to reduce potential off-label use, fenfluramine oral solution is available through a controlled access program
Ref: UCB | Image: UCB
Click here to read the full press release
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.