UCB Gets US FDA Approval for Psoriasis Drug

By Helena Smolak

UCB received approval from the U.S. Food and Drug Administration for a drug to treat severe plaque psoriasis for which the company expects global peak annual sales of at least 4 billion euros ($4.23 billion).

The Belgian biopharmaceutical firm said Wednesday that its bimekizumab drug, which will be commercialized as Bimzelx, was approved by the FDA as a treatment for the skin disease psoriasis in adults.

"With bimekizumab now approved for psoriasis, we will move forward rapidly to submit applications for additional indications in the U.S.", it said.

The FDA approval was backed by data from three Phase 3 studies, the company said.

UCB on Tuesday said the FDA approved its Zilbrysq for the treatment of adults with myasthenia, an autoimmune disorder.

Write to Helena Smolak at [e-mail]

(END) Dow Jones Newswires

10-18-23 1121ET