Almirall, S.A. Receives European Commission Approval of Klisyri® (Tirbanibulin)
July 19, 2021 at 10:17 am EDT
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Almirall S.A. announced that theEuropean 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 reported prevalence of AK in the European population is around 18% and its incidence is predicted to increase globally due to an aging population, increased exposure to UV radiation, and changes in UV-seeking behaviors. 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. In addition, the company has submitted Klisyri® for a marketing authorisation in Switzerland in Fourth Quarter 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.
Almirall SA is a Spain-based company principally engaged in the pharmaceuticals manufacture. The Company focuses on development and marketing of drugs applied in various therapeutic areas, such as nervous system, gastrointestinal, dermatological, respiratory system, antiinfectives, as well as antineoplastic and immunomodulating agents. The Company's activities are divided into four business segments: Own network, which focuses on the commercialization of pharmaceuticals through own brand names; Licenses, which sells product rights to third parties; Research and development (R&D), which is responsible for the creation of drug candidates, as well as Dermatology, which includes sale of dermatological medicines in the United States. The Company operates through numerous subsidiaries in Europe, the Americas, Africa, Asia and Australia.
ALMIRALL, S.A. 
