EXTON, PA — Almirall, S.A. (BME: ALM), a global biopharmaceutical company focused on skin health, announced that Klisyri® (tirbanibulin) has been approved by the U.S. Food and Drug Administration (FDA) for the topical treatment of actinic keratosis (AK) of the face or scalp. Klisyri® (tirbanibulin) will be launched in the US during the first quarter of 2021.
Klisyri® is a novel, topical first-in-class microtubule inhibitor that represents a significant step forward in the treatment of AK due to its short treatment protocol (once daily application for 5 days), and proven efficacy and safety profile. Actinic keratosis is the second most common diagnosis made by dermatologists in the United States.1 The reported prevalence of AK is between 11% and 25%.3
“Early diagnosis and treatment of actinic keratosis (AK) is critical, since those who already have an AK are likely to develop more actinic keratoses (plural) in the future,” said Deborah S. Sarnoff, MD, President of the Skin Cancer Foundation. “Patients with AK are at higher risk for skin cancer, since AKs can progress into squamous cell carcinoma (SCC), a common and sometimes invasive form of skin cancer.”
The FDA approved Klisyri® (tirbanibulin) based on the data from one of the largest Phase III clinical study programs ever conducted for a topical AK treatment, two pivotal, randomized, double-blind, vehicle-controlled Phase III studies (KX01-AK-003 and KX01-AK-004) that evaluated the efficacy and safety of Klisyri® (tirbanibulin) ointment 1% in adults with actinic keratosis on the face or scalp.
“These studies enrolled a total of 702 patients across 62 sites in the United States, providing robust data. Tirbanibulin achieved a significantly higher number of patients with complete (100%) clearance of AK lesions in the treated area compared to vehicle (44% vs. 5% in study 1 and 54% vs. 13% in study 2), as well as reaching the secondary endpoint of partial (≥75%) clearance of lesions,” stated Andrew Blauvelt, MD, MBA, President of Oregon Medical Research Center, and one of the lead investigators of the studies.
Ayman Grada, MD, head of R&D and Medical Affairs for Almirall US went on to explain, “In addition to proven efficacy, Klisyri demonstrated safety, with the most common adverse events being application site pruritus and pain seen in 9% and 10% respectively of patients treated with it. Of note, no patients withdrew from the study due to adverse events.”
Klisyri® (tirbanibulin) is supplied in boxes of 5 single-use sachets, and is applied to the treatment area once daily for 5 days. “The convenient dosing regimen should lead to better patient compliance,” continued Dr. Grada.
Pablo Alvarez, President and General Manager of Almirall US, summarized, “The approval of Klisyri marks another important milestone for Almirall towards our goal to be a leader in the field of dermatology. We believe that this treatment, with its 5-day treatment course and proven efficacy and tolerability, make it an important therapeutic option for dermatologists and their patients. We appreciate the efforts of Athenex from discovery, to development, to approval of Klisyri, and we look forward to launching this exciting product in early 2021.”
1 Wilmer EN, Gustafson CJ, Ahn CS, Davis SA, Feldman SR, Huang WW. Most common dermatologic conditions encountered by dermatologists and nondermatologists. Cutis. 2014 Dec;94(6):285-92.
2 Phase III studies KX01-AK-003 (NCT03285477) and KX01-AK-004 (NCT03285490)
3 Stockfleth E, Ferrandiz C, Grob JJ, et al. Development of a treatment algorithm for actinic keratoses: a European Consensus. Eur J Dermatol. 2008;18(6):651–659
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