UCB's Fintepla approved for LGS in Europe

Belgian drug major UCB’s (Euronext: UCB) shares were up 2% at 77.70 euros this morning, on the news that Fintepla (fenfluramine) oral solution has been approved by the European Commission for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) as an add-on therapy to other anti-epileptic medicines for patients two years of age and older.

The approval was based on safety and efficacy data from a global, randomized, placebo-controlled Phase III clinical trial, in 263 patients with LGS (aged 2-35 years), that demonstrated adjunctive fenfluramine at a dose of 0.7/mg/kg/day provided a significantly greater reduction in the frequency of drop seizures (p=0.001) compared to placebo. The most common treatment-emergent adverse events were decreased appetite, somnolence, fatigue, and pyrexia (fever). No cases of valvular heart disease or pulmonary arterial hypertension were observed.

UCB acquired rights to Fintepla along with its takeover of USA-based biotech Zogenix last year, in a total transaction valued at up to around $1.9 billion/1.7 billion euros, with a contingent value right (CVR) for a potential cash payment of $2.00 upon European Union approval of the drug. The drug gained US approval for the treatment of LGS- and Dravet syndrome-associated seizures in March 2020.