The US Food and Drug Administration has approved a supplemental new drug application for tirbanibulin topical ointment, allowing the expansion of the surface area treated for actinic keratosis (AK) of the face or scalp from 25 cm² to 100 cm².

Tirbanibulin is a microtubule inhibitor, approved for the topical treatment of AK of the face and scalp in 2020. According to a press release from Almirall, which markets topical tirbanibulin under the brand name Klisyri, the expanded approval was based on results from a phase 3, multicenter, open-label, clinical safety study in the United States, which evaluated the safety and tolerability of applying tirbanibulin to a field of approximately 100 cm² on the face or balding scalp of adults with AK. Results were consistent with the results in the original pivotal trials that were conducted on an area of 25 cm².

Tirbanibulin will be available in two package sizes: 250 mg for the treatment of up to 25 cm² and 350 mg for up to 100 cm².