The U.S. Food and Drug Administration (FDA) has approved tirbanibulin (Klisyri, Almirall) for the treatment of actinic keratosis on an expanded area of the scalp and face, according to a news release from the manufacturer. 

The tirbanibulin ointment, 1% is a microtubule inhibitor with a five-day application period, which is also the shortest of any topical treatment for actinic keratosis, according to the manufacturer. The approval for the expanded area of the face and scalp (up to 100 cm²) in patients with actinic keratosis builds upon the original approval for treatment of an area of 25 cm² in 2020). 

“The FDA’s approval of the use of Klisyri for actinic keratosis on an extended surface of the face or scalp is a significant step forward for both patients and treating dermatologists," saidKarl Ziegelbauer, Chief Scientific Officer at Almirall in a company press announcement. "With patients experiencing AK over larger surface areas, dermatologists are looking for ways to treat the entire affected area to help prevent further lesion progression.”

 The approval follows the released results of a phase 3 trial U.S. with more than 100 enrolled patients with actinic keratosis which showed an acceptable safety and toleratily profile for tirbanibulin for the 100 cm² expanded surface area or balding scalp of adult patients. The results were consistent with its pivotal trials that were conducted in the smaller surface area

“With this new FDA approval, clinicians can now treat up to four times the surface area, allowing increased flexibility to provide treatment of actinic keratoses and achieve effective results with a good safety and tolerability profile for more patients,” Practical Dermatology Chief Medical Editor Neal Bhatia, MD, from San Diego, CA, who served as the principal investigator for the larger treatment area pivotal study, said in the release. 

The manufacturer says the product 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.

Source: Almirall press release. June 10, 2024.