FDA expands Approval of Tirbanibulin for Actinic Keratosis on Larger Areas of Face and Scalp

Almirall, a global pharmaceutical company dedicated to medical dermatology, announced today that the U.S. Food and Drug Administration (FDA) has approved Almirall’s recent supplemental New Drug Application (sNDA) to expand the use area for its drug, Klisyri, to up to 100 cm2. Klisyri, a microtubule inhibitor ointment, is now approved in a 350 mg package size and is a 5-day topical field treatment for actinic keratosis (AK) of the face or scalp.

“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. 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,” says Karl Ziegelbauer, Chief Scientific Officer at Almirall.

This new approval will change 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. The sNDA was supported by an additional Phase 3, multicenter, open-label, clinical safety study with more than 100 patients in the US. The primary endpoints of the study were to evaluate 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 (AEs).

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.

“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,” says Neal Bhatia, MD, from San Diego, CA, who served as the principal investigator for the larger treatment area pivotal study.

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.

About Klisyri:

Klisyri tirbanibulin ointment, 1% is a microtubule inhibitor indicated for the topical field treatment of actinic keratosis (AK) of the face or scalp. Klisyri has a demonstrated efficacy and safety profile, and a convenient 5-day application period, which is the shortest of any topical treatment for AK.

About Actinic Keratosis:

Actinic keratosis or solar keratosis is a chronic and precancerous skin disease that occurs primarily in areas that have been exposed to ultraviolet (UV) radiation for a long period of time. It is usually found on the face, ears, lips, bald scalp, forearms, the posterior part of the hands, and lower legs. It is not possible to predict which AK lesions will develop into squamous cell carcinoma, so all lesions should be treated by a dermatologist. Actinic keratosis is the most common pre-cancerous dermatological condition. AK is the second most common diagnosis made by dermatologists in the United States. The reported prevalence of AK is between 11% and 25%.