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Tirbanibulin (Klisyri) treatment of actinic keratosis now allowed over larger surface areas

June 13, 2024

The FDA has approved use of Klisyri (tirbanibulin)—a microtubule inhibitor ointment—on larger areas of the face or scalp (up to 100 cm2) to address more extensive manifestations of actinic keratosis (AK). Klisyri was originally approved in December 2020.

AK is the most common pre-cancerous dermatological condition and the second most common diagnosis made by dermatologists in the U.S. with a reported prevalence of between 11% and 25%.

• This new approval changes the previous Klisyri (tirbanibulin) dosing for surface area treatment from up to 25 cm2 to up to 100 cm2, allowing clinicians to treat a larger area of the face or balding scalp.
• FDA's approval was supported by an additional Phase 3, multicenter, open-label, clinical study with more than 100 patients in the U.S. that evaluated the safety and tolerability of applying tirbanibulin to a field of approximately 100 cm2 on the face or balding scalp of adult AK patients.
• The study showed consistent results with the original pivotal trials conducted on an area of 25 cm2, for both local skin reactions and treatment-related adverse events.
• The effectiveness of tirbanibulin in a larger treatment area was also explored, showing a percent reduction in AK lesion count in line with the one reported in the original pivotal studies.
• Klisyri will be available in two package sizes, 250 mg (NDC 16110-391-05) for the treatment of up to 25 cm2, and 350 mg (NDC 16110-391-55)] for up to 100 cm2.

Source:

(2024, June 10). Almirall. [Press release]. FDA approves Almirall's Klisyri® (tirbanibulin) for the treatment of actinic keratosis on expanded area of face or scalp up to 100 cm2. 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