FDA Approves Almirall’s Klisyri for Expanded Treatment Area of Actinic Keratosis

The US Food and Drug Administration (FDA) has recently approved an expansion for the use of Klisyri (tirbanibulin) to treat actinic keratosis (AK) on larger areas of the face or scalp, up to 100 cm². Initially approved in December 2020 for areas up to 25 cm², this new approval significantly increases the treatment area, providing greater convenience for both patients and dermatologists.

Tirbanibulin, a microtubule inhibitor ointment, is now available in a 350-mg package for a 5-day topical treatment. This expansion follows a phase 3 clinical safety study involving over 100 patients. The study demonstrated that treating up to 100 cm² is as safe and tolerable as the originally approved 25 cm² area, with consistent results in local skin reactions and treatment-related adverse events.

Karl Ziegelbauer, chief scientific officer at Almirall, highlighted the significance, “This approval allows dermatologists to treat larger areas affected by AK, helping to prevent lesion progression and providing a more comprehensive treatment option.”

The effectiveness of tirbanibulin for larger areas was also confirmed, showing a reduction in AK lesion count similar to previous studies. Neal Bhatia, MD, the principal investigator for the study, noted, “Clinicians can now treat up to 4 times the surface area, enhancing flexibility and achieving effective results with a good safety profile for more patients.”

Tirbanibulin will be available in 2 package sizes: 250 mg for up to 25 cm² and 350 mg for up to 100 cm².

Reference

1. FDA approves Almirall’s Klisyri (tirbanibulin) for the treatment of actinic keratosis on expanded area of face or scalp up to 100 cm². News release. Almirall. June 10, 2024. Accessed June 11, 2024. https://www.almirall.com/newsroom/news/fda-approves-almirall-s-klisyri-tirbanibulin-for-the-treatment-of-actinic-keratosis-on-expanded-area-of-face-or-scalp-up-to-100-cm2