Scienza e Tecnologia
Almirall receives European Commission approval of Klisyri®▼ (tirbanibulin), an innovative topical treatment for actinic keratosis
Tirbanibulin is a novel, topical first-in-class microtubule inhibitor with a selective antiproliferative mechanism of action that represents a significant .
" stated , Almirall's Chief Executive Officer.
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 behaviours.
, MD PhD, Chief Dermatology Service at the Hospital Clinic in Barcelona .
This approval is based on two pivotal , published in the New England Journal of Medicine (NEJM) . These two double-blind, vehicle-controlled, randomised, parallel-group, multi-centre 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 December 2020 , Almirall's development partner, Athenex, Inc., received approval from the (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 (CHMP) of the EMA issued a positive opinion for the regulatory approval of Klisyri .
In addition, Almirall submitted Klisyri for a marketing authorisation in Switzerland in December 2020 and the dossier is currently under review by Swissmedic. The company has already submitted in Great Britain via the European Commission Decision Reliance Procedure.
Logo - https://mma.prnewswire.com/media/1217694/Almirall_Logo.jpg