Athenex’s Actinic Keratosis Ointment Wins FDA Nod

The FDA has approved Athenex’s Klisyri (tirbanibulin) as a topical face and scalp ointment for treating actinic keratosis (AK), the company’s first approval in the U.S.

The approval was supported by results from two phase 3 studies evaluating the drug in 702 adults, which found the drug cleared AK lesions in treated patients after 57 days.

New York-based Athenex has a U.S. and EU distribution deal with Spanish biotech firm Almirall and plans to launch the newly approved product in the U.S. early next year.