UCB's Rare Childhood Epilepsy Drug Scores FDA Approval

The FDA approved UCB SA's UCBJY drug to treat seizures associated with Lennox-Gastaut Syndrome (LGS), a rare form of childhood epilepsy.
The drug, branded as Fintepla, is approved in the U.S. to treat another form of childhood-onset epilepsy, Davet Syndrome (DS), in patients aged two years and older.
LGS causes cognitive dysfunction and frequent seizures.
Developed by Zogenix, Fintepla is available only through a restricted drug distribution program in the U.S.
Related: UCB to Buy Epilepsy-Focused Zogenix In $1.9B Deal: See The Highlights.
The FDA approval was supported by safety and efficacy data from a Phase 3 clinical trial in 263 patients with LGS.
Fintepla at a dose of 0.7 mg/kg/day significantly reduced monthly drop seizures frequency by a median of 23.7% from baseline compared to 8.7% placebo.
Nearly a fourth of those patients on FINTEPLA 0.7 mg/kg/day experienced a ≥50% reduction in drop seizure frequency per 28 days; 18% with ≥50% to <75% reduction and 6% ≥75% reduction.
Price Action: UCBJY shares are trading at $59.56 during the market session on the last check Monday.