UCB’s Childhood Epilepsy Drug Gets FDA Nod

Belgium-based biopharmaceutical company UCB SA (UCBJF) has received the green light from the U.S. Food and Drug Administration (FDA) for its drug, Fintepla, to treat Lennox-Gastaut Syndrome (LGS), a rare form of childhood epilepsy, a report published by Reuters said.

Fintepla is already approved in the U.S. for the treatment of Davet Syndrome (DS), another form of childhood epilepsy, in children aged at least two.

Children suffering from LGS experience seizures and cognitive dysfunction that can cause injury. According to Zogenix, a unit of UCB, around 30,000 to 50,000 kids in the U.S. have LGS.

The FDA approved Fintepla for LGS on the basis of safety and efficacy data from a Phase III clinical trial that enrolled 263 patients with LGS. The drug will be available in the U.S. only via a restricted drug distribution program.

Based out of Brussels, UCB is focused on the research and development of medications centered on epilepsy, Parkinson’s disease, and Crohn’s disease.

Wall Street Weighs In

Bernstein analyst Wimal Kapadia expects Fintepla’s global sales to reach $300 million from LGS indication by the end of this decade. The figure could total $800 million from both indications.

Fintepla will compete against Jazz Pharmaceuticals’ (NASDAQ: JAZZ) Epidiolex, which is approved in the U.S. to treat both LGS and DS. However, UCB’s drug is relatively expensive and its LGS data is not differentiated. “This could restrict its use to patients who have failed two prior lines of therapy,” Kapadia said.

“In the DS indication it is clear that Fintepla is a superior product, but I think that’s less true for the LGS indication,” the analyst added.

Price Target

Based on four Buys and four Holds, UCB has a Moderate Buy consensus rating. UCB’s average price target of $116.57 implies 10% upside potential from current levels. Shares have gained 10.7% over the past year.

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