BRIEF—Almirall receives EC approval of Klisyri

Spain’s largest drugmaker Almirall says it has received approval from the European Commission for Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp in adults.

“The approval of Klisyri represents a breakthrough for actinic keratosis patients, who seek new treatments that could offer them 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 the firm’s chief executive, Gianfranco Nazzi.

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.

In December 2020, Almirall’s development partner, Athenex, gained approval from the US Food and Drug Administration for the commercialization of Klisyri in the USA for the topical treatment of AK of the face or scalp.

In addition, Almirall submitted Klisyri for a marketing authorization 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.