Almirall receives European Commission approval of Klisyri® (tirbanibulin), an innovative topical treatment for actinic keratosis

BARCELONA, Spain, July 19, 2021 /PRNewswire/ -- Almirall S.A. (BME: ALM), a global biopharmaceutical company, announced today that the European Commission (EC) has approved Klisyri^® (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp in adults.

Tirbanibulin is a novel, topical first-in-class microtubule inhibitor with a selective antiproliferative mechanism of action that represents a significant step forward in the treatment of AK due to its short treatment protocol, one application daily for 5 days, proven efficacy, and safety profile with very acceptable local tolerability.

"The approval of Klisyri^® represents a breakthrough for actinic keratosis patients, who seek for new treatments that could offer them a better tolerability and short treatment duration. We have once again demonstrated Almirall's commitment to promoting future value through innovation and differentiated therapies with the potential to make a significant difference to patients' lives", stated Gianfranco Nazzi, Almirall's Chief Executive Officer. 

The reported prevalence of AK in the European population is around 18%^[2],[3] and its incidence is predicted to increase globally due to an aging population, increased exposure to UV radiation, and changes in UV-seeking behaviors.^[4] "AK is the most frequent pre-cancerous skin disease and it is thought to be underdiagnosed or considered just as sun damaged skin. Treating AK is crucial since it can progress to skin cancer with its associated burden in the future. With tirbanibulin, patients could significantly improve their AK lesions, using a 5-day convenient dose regimen." Susana Puig, MD PhD, Chief Dermatology Service at the Hospital Clinic in Barcelona.

This approval is based on two pivotal phase III studies' (KX01-AK-003 and KX01-AK-004) positive results, published in the New England Journal of Medicine (NEJM)^[1]  These two double-blind, vehicle-controlled, randomized, parallel-group, multi-center phase III clinical trials,  included 702 patients from 62 clinical sites across the US, and demonstrated  that once-daily application of tirbanibulin ointment 1% (10 mg/g) during 5 consecutive days in adults with AK on the face or scalp is effective and generally well tolerated.

Both phase III studies achieved their primary endpoint, which was defined as 100% clearance (Complete Clearance) of the AK lesions on Day 57 in the face or scalp treatment areas, each study achieving statistical significance (p<0.0001) versus vehicle on this endpoint. In the KX01-AK-003 study, complete clearance was observed in 44% of the patients treated with tirbanibulin versus 5% for vehicle-treated groups. In the KX01-AK-004 study, complete clearance was observed in 54% of the patients treated with tirbanibulin versus 13% for vehicle-treated groups. Local reactions were mostly mild-to-moderate erythema, flaking or scaling, application-site pruritus, and application-site pain that was resolved spontaneously^[3]. 

In December 2020, Almirall's development partner, Athenex, Inc., received approval from the U.S. Food and Drug Administration (FDA) for the commercialisation of Klisyri^® (tirbanibulin) in the United States for the topical treatment of AK of the face or scalp. Later, in May 2021, the Committee for Medicinal Products for Human Use (CHMP) of the EMA issued a positive opinion for the regulatory approval of Klisyri^®.

In addition, Almirall has submitted Klisyri^® for a marketing authorisation in Switzerland in Q4 2020 and the dossier is currently under review by Swissmedic. The company has already submitted it in Great Britain via the European Commission Decision Reliance Procedure.

[1] Blauvelt A, Kempers S, Lain E, et al. Phase 3 Trials of Tirbanibulin Ointment for Actinic Keratosis. N Engl J Med. 2021 Feb 11;384(6):512-520. doi: 10.1056/NEJMoa2024040 

[2] Lucas R, McMichael T, Smith W, Armstrong B. Solar ultraviolet radiation: Global burden of disease from solar ultraviolet radiation: World Health Organization, 2006. 

[3] Worldometer. Population of Europe. 2020. Available at: https://www.worldometers.info/world-population/europe-population/ Accessed: October 2020. 

[4] Chetty P, Choi F, Mitchell T. Primary care review of actinic keratosis and its therapeutic options: a global perspective. Dermatol Ther (Heidelb) 2015;5(1):19-35

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