- The initial FDA approval (December 2020) has now been expanded to use Klisyri on larger areas (up to 100 cm2) of the face or scalp to address a broader spectrum of actinic keratosis manifestations, providing patients and dermatologists with Come to convenience
- Safety and tolerability of Klisyri for treatment of actinic keratosis up to 100 cm2 (4 times the originally approved 25 cm2 treatment area) consistent with initial pivotal trial results
- Actinic keratosis is the most common precancerous skin disease and the second most common diagnosis made by dermatologists in the United States, with a reported prevalence ranging from 11% to 25%2-3
MALVERN, Pa.–(BUSINESS WIRE)–Almirall, a global pharmaceutical company dedicated to medical dermatology, today announced that the U.S. Food and Drug Administration (FDA) has approved Almirall’s recent supplemental New Drug Application (sNDA) to expand its use. Its drug Klisyri has an area of up to 100 cm2. Klisyri, a microtubule inhibitor ointment, is now approved in a 350 mg package size as a 5-day topical spot treatment for the treatment of actinic keratosis (AK) on the face or scalp.
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Almirall headquarters in Barcelona (Photo: Business Wire)
The FDA’s approval of Klisyri to treat actinic keratosis on the extended surfaces of the face or scalp is an important step forward for both patients and dermatologists. As patients experience AK over a larger surface area, dermatologists are looking for ways to treat the entire affected area to help prevent further progression of the lesions, explain Karl Ziegelbauer, Chief Scientific Officer, Almirall.
This new approval will change the dosage of Klisyri (tirbanibulin) previously used for surface area treatment from up to 25 cm2 to up to 100 cm2, allowing clinicians to treat larger areas of the face or bald scalp. The sNDA is supported by another Phase 3, multicenter, open-label clinical safety study of more than 100 patients in the United States. The primary endpoint of the study was to assess the safety and tolerability of tibanibulin applied to an area of approximately 100 cm2 on the face or bald scalp of adult patients with AK. The results of the study showed local skin reactions and treatment-related adverse events (AEs) consistent with the results of the initial pivotal trial conducted in a 25 cm2 area.
The effectiveness of tibanibulin in a larger treatment area was also explored, and the results showed a percentage reduction in AK lesion counts consistent with that reported in the original pivotal study.
With this new FDA approval, clinicians can now treat up to four times more surface area, increasing flexibility in treating actinic keratosis and providing more patients with favorable safety and tolerability profiles. to obtain effective results, explain Neil Bhatia, MD, from San Diego, Calif., where he serves as principal investigator for pivotal studies in the larger treatment area.
Klisyri will be available in two package strengths, 250 mg (NDC 16110-391-05) for treating areas up to 25 cm2 and 350 mg (NDC 16110-391-55) for treating areas up to 100 cm2.
Important safety information
Warnings and Precautions
Eye adverse reactions
Klisyri may cause eye irritation. Avoid transfer of medication to the eyes and periocular area during and after use. Wash hands immediately after use. If accidental exposure occurs, instruct patients to flush eyes with water and seek medical attention as soon as possible.
local skin reaction
After topical application of Klisyri, local skin reactions, including severe reactions (erythema, flaking/scaling, crusting, swelling, vesicles/pustules, and erosions/ulcers), may occur in the treated area. Avoid use until skin has healed from any previous medication, procedure, or surgical treatment. Occlusion after topical application of Klisyri is more likely to cause irritation.
Adverse reactions
The most common adverse reactions (incidence ≥2%) are local skin reactions, itching at the application site, and pain at the application site.
Click here for complete prescribing information.
About Crissili: Klisyri tirbanibulin ointment, 1% is a novel microtubule inhibitor indicated for the topical on-site treatment of actinic keratosis (AK) on the face or scalp. Klisyri has proven efficacy and safety, as well as a convenient 5-day usage period, the shortest of all topical treatments for AK.1
About Actinic Keratosis: Actinic keratosis, or solar keratosis, is a chronic, precancerous skin disease that occurs primarily in areas that are chronically exposed to ultraviolet (UV) radiation. It usually appears on the face, ears, lips, bald spots, forearms, back of hands, and calves. It is impossible to predict which AK lesions will develop squamous cell carcinoma, so all lesions should be treated by a dermatologist. Actinic keratosis is the most common precancerous skin disease. AK is the second most common diagnosis among dermatologists in the United States.
About Almiral
Almirall is a global pharmaceutical company dedicated to medical dermatology. We work closely with leading scientists, healthcare professionals and patients to achieve our goals: Changing patients’ worlds by helping them realize their hopes and dreams for healthy living. We are at the forefront of science, delivering breakthrough, differentiated medical dermatology innovations that meet patient needs.
Almirall was founded in 1944, is headquartered in Barcelona, and is listed on the Spanish Stock Exchange (ticker symbol: ALM, total revenue in 2023: 898.8 MM Euros, 1900 employees worldwide). Almirall products help improve patients’ lives every day and are sold in more than 100 countries.
For more information, please visit https://www.almirall.us/
Legal Notices:
This document contains summary information only and is not exhaustive. The facts, data and opinions contained in this document, other than historical facts, data and opinions, are “forward-looking statements”. These statements are based on currently available information and the best estimates and assumptions that the Company believes to be reasonable. These statements involve risks and uncertainties beyond the Company’s control. Accordingly, actual results may differ materially from those stated in such forward-looking statements. The Company expressly disclaims any obligation to revise or update any forward-looking statements, targets or estimates contained in this document to reflect any changes in assumptions, events or circumstances on which such forward-looking statements are based, unless requested by the Company.
refer to:
- Crisili [package insert]. Malvern, PA: Admiral LLC.
- Wilmer EN, Gustafson CJ, Ahn CS, Davis SA, Feldman SR, Huang WW. The most common skin conditions encountered by dermatologists and non-dermatologists alike. skin. 2014;94(6):285-92.
- Lim HW, MD, Collins SAB, et al. Burden of skin diseases in the United States. J Am Acad Dermatol Magazine. 2017;76:958-72.
US-TIRBA-2400068 06/2024
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