www.fdanews.com/articles/200515-athenexs-actinic-keratosis-ointment-wins-fda-nod
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Athenex’s Actinic Keratosis Ointment Wins FDA Nod
December 17, 2020
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.