Athenex Inc (NASDAQ: ATNX) is a global biopharma firm that concentrates on the commercialization, discovery, and development of novel therapeutic treatments for cancer and other related conditions. It recently announced that Almirall, S.A., its partner, has received European Commission approval to market its Klisyri drug. Klisyri is designed to treat actinic keratosis of both the scalp and face of adults. Almirall launched this drug in the United States in 2021. The company will also be launching in Europe very soon.
Tirbanibulin is a topical first-in-class novel microtubule inhibitor with a selective anti-proliferative system of action, proving to be a trailblazer in the A.K. treatment space because of the drug’s short treatment protocol, safety profile, and proven efficacy.
Approval is just another milestone
Athenex’s Chief Executive Officer, Johnson Lau, said that this European Commission approval signifies another milestone for Klisyri. This isn’t so long after the drug has been both approved for marketing and launched in the United States. The CEO further stated that they were happy that patients and physicians all over Europe now have access to new A.K. treatment solutions that have both excellent tolerability and short treatment protocols.
The positive results recorded in pivotal Phase 3 studies (KX01-AK-004 and KX01-AK-003) helped the company get this approval. These two vehicle-controlled, double-blind, parallel-group, randomized, multi-center Phase 3 trials consisted of 702 patients across 60 clinical sites in the United States. Both studies met their primary endpoints, one of them being a 100% clearance of A.K. lesions on both the scalp and face by the 57th day of application. In the first study, complete clearance of the lesions was seen about 44% of the participants. In the second study, complete clearance was seen in about 54% of the participants.
In addition to all this, Almirall wants market authorization for Klisyri in Switzerland as well, and Swissmedic is currently reviewing their submission. The company has also made submissions in Great Britain through the ECDRP (European Commission Decision Reliance Procedure). Actinic keratosis is a precancerous and chronic skin disorder that arises because of long exposure to U.V. rays.