Klisyri® (tirbanibulin; Almirall) ointment is now available for the topical treatment of actinic keratosis (AK) of the face or scalp in adults.
Klisyri is a novel, first-in-class microtubule inhibitor. The approval was based on data from 2 multicenter, randomized, double-blind, phase 3 trials (ClinicalTrials.gov: NCT03285477 [N=351] and NCT03285490 [N=351]) that compared the efficacy and safety of Klisyri ointment to placebo in adults with AK on the face or scalp. Results from both studies showed that Klisyri-treated patients achieved statistically significant clearance of AK lesions at day 57, when compared with placebo.
With regard to safety, the most common adverse reactions (incidence of greater than or equal to 2%) reported with Klisyri were local skin reactions, application site pruritus, and application site pain.
Klisyri is supplied in boxes of 5 single-use packets containing 25mg of tirbanibulin ointment 1%.
For more information visit klisyri.com.
Athenex announces U.S. launch of Klisyri® and licensing of additional territories for tirbanibulin. [press release]. Buffalo, NY: Athenex, Inc; February 18, 2021.