FDA Approves Almirall's Klisyri for Treating Actinic Keratosis on Larger Facial or Scalp Areas

June 10, 2024 - Almirall, a prominent global pharmaceutical firm specializing in medical dermatology, announced that the U.S. Food and Drug Administration (FDA) has endorsed its supplemental New Drug Application (sNDA) for Klisyri. This approval allows the microtubule inhibitor ointment to treat actinic keratosis (AK) on areas as large as 100 cm², a significant increase from the previous limit of 25 cm². Klisyri is now available in a 350 mg package for this purpose and remains a 5-day topical treatment aimed at AK on the face or scalp.

Advancement in AK Treatment

Karl Ziegelbauer, Chief Scientific Officer at Almirall, remarked on the importance of this FDA approval, highlighting its potential benefits for both patients and dermatologists. AK often affects larger skin areas, and the ability to treat up to 100 cm² is expected to enhance clinical outcomes by addressing the entire affected region more effectively, potentially inhibiting further lesion development.

Clinical Validation

The sNDA approval was underpinned by a Phase 3, multicenter, open-label clinical safety study involving over 100 U.S. patients. The primary objectives were to assess the safety and tolerability of applying tirbanibulin to a 100 cm² area of the face or balding scalp in adults with AK. The study’s findings were consistent with initial pivotal trials for the smaller 25 cm² area, in terms of both local skin reactions and treatment-related adverse events (AEs). The larger treatment area also demonstrated a comparable reduction in AK lesion counts to the original studies.

Broader Clinical Application

Dr. Neal Bhatia from San Diego, CA, who led the pivotal study, emphasized that the new FDA approval enables clinicians to treat up to four times the previous surface area. This increased flexibility is expected to deliver effective AK treatment with a strong safety and tolerability profile.

Product Availability

Klisyri will now be available in two package sizes: 250 mg for treating up to 25 cm² and 350 mg for treating up to 100 cm², providing options tailored to different treatment needs.

Safety Information

Users should take precautions to avoid eye irritation during and after applying Klisyri. Accidental exposure to the eyes requires immediate rinsing with water and medical consultation. Local skin reactions can occur and may include severe effects such as erythema, flaking, scaling, and ulceration. Such reactions are more likely if the skin has not healed from previous treatments. The most common adverse reactions, observed in at least 2% of users, include localized skin reactions, itching at the application site, and pain at the application site.

About Klisyri and Actinic Keratosis

Klisyri (tirbanibulin ointment, 1%) is a novel microtubule inhibitor for the topical treatment of AK, involving a convenient 5-day application period. AK, also known as solar keratosis, is a chronic and precancerous skin disorder predominantly found in areas with prolonged UV exposure, such as the face, scalp, and forearms. It is imperative to treat all AK lesions since it is unpredictable which might progress to squamous cell carcinoma. AK is the most frequently diagnosed pre-cancerous skin condition and the second most common dermatological diagnosis in the U.S., with a prevalence of 11% to 25%.

About Almirall

Founded in 1944 and headquartered in Barcelona, Almirall is dedicated to advancing medical dermatology. The company collaborates closely with scientists, healthcare professionals, and patients to deliver innovative dermatology treatments. Almirall is publicly traded on the Spanish Stock Exchange and operates in over 100 countries, employing around 1,900 people globally.

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