FDA Approves Expanded Use for Almirall’s Klisyri in Actinic Keratosis Treatment

MALVERN, PA — Almirall announced that the U.S. Food and Drug Administration (FDA) recently approved an expansion for its drug Klisyri, allowing it to be used over a larger surface area for treating actinic keratosis (AK) on the face or scalp. The latest approval increases the permissible treatment area from up to 25 square centimeters to 100 square centimeters.

Klisyri, a microtubule inhibitor ointment, is now available in a 350 mg package size and is prescribed as a 5-day topical treatment for AK. Actinic keratosis is a common skin condition caused by long-term sun exposure, which can lead to rough, scaly patches or lesions on the skin.

“The FDA’s approval to expand Klisyri’s use on a larger area of the face or scalp is significant for both patients and dermatologists,” said Karl Ziegelbauer, Chief Scientific Officer at Almirall. “Patients often experience AK over substantial surface areas, and this approval allows dermatologists to treat the entire affected region, potentially preventing further lesion progression.”

The approval follows an additional Phase 3 clinical safety study conducted across multiple centers in the U.S. Involving over 100 patients, the study aimed to evaluate the safety and tolerability of applying tirbanibulin, the active ingredient in Klisyri, to an area of approximately 100 square centimeters. Results showed consistent outcomes with earlier pivotal trials focused on smaller areas. Both local skin reactions and treatment-related adverse events were in line with expectations.

Neal Bhatia, MD, principal investigator for the study, emphasized the benefits of the new approval. “Clinicians can now treat up to four times the surface area, giving them greater flexibility to manage actinic keratoses effectively. This provides a good safety and tolerability profile for more patients,” he said.

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The expansion allows dermatologists to offer a more comprehensive treatment option for patients with extensive AK, enhancing the ability to manage and potentially reduce the presence of lesions. The move underscores Almirall’s commitment to advancing dermatological treatments and addressing the needs of patients with broader skin conditions.

With this new FDA approval, Klisyri stands poised to make a more significant impact in the treatment of actinic keratosis, providing a practical solution for a condition affecting millions of people.

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