As UCB works to secure U.S. approval for its promising plaque psoriasis prospect bimekizumab, the company has landed an FDA nod in a rare disease where it will challenge Jazz Pharmaceuticals.
Fintepla, acquired by UCB in the company's recent $1.9 billion buyout of Zogenix, has scored an FDA label expansion to treat seizures associated with Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood epilepsy. In the disease, Fintepla will challenge Jazz Pharma's cannabinioid drug Epidiolex, which is approved to treat seizures in patients with LGS, Dravet syndrome, or tuberous sclerosis complex (TSC) in patients 1 year of age and older.
Before the Monday expansion, Fintepla was already approved to treat seizures associated with Dravet syndrome in patients 2 and older. In a note to clients, Bernstein analyst Wimal Kapadia said the LGS use could be worth $300 million in 2030 sales for the medicine, Reuters reports. He predicts the pair of uses will generate about $800 million.
The FDA based its LGS approval on data from a phase 3 trial in 263 patients. In the study, Fintepla at a dose of 0.7 mg/kg per day reduced the number of monthly drop seizures—in which patients fall to the floor and often sustain injuries—by a median of 23.7% from baseline. For patients on placebo, the reduction was 8.7% from baseline.
For UCB, the Zogenix buyout and Fintepla label expansion come as blockbuster seizure drug Vimpat is expected to face near-term generic competition. The drug generated $1.27 billion in the U.S. last year, and UCB has said it could face U.S. generics as soon as this month.
Meanwhile, UCB is also awaiting a high-stakes FDA decision on plaque psoriasis prospect bimekizumab. The drug, expected to become a blockbuster, originally had an FDA decision date of Oct. 15, 2021. A day after the deadline, though, UCB said the FDA had to delay the decision because inspectors couldn't get over to Europe to review UCB's manufacturing operations due to COVID-related travel restrictions.
At the time, UCB said it would work with the agency to schedule the inspection.
Before the delay, bimekizumab was one of the most anticipated drug launches in 2021, with projected 2026 sales of $1.63 billion. Meanwhile, bimekizumab has picked up approvals from regulators in Europe, Japan and Canada.