ATNX - Athenex says Almirall's klisyri treatment gets positive CHMP opinion

Athenex ([[ATNX]] +0.4%) announces that its partner, Almirall, has received a positive opinion from the Committee for Medicinal Products for Human Use ((CHMP)) of EMA for the regulatory approval of Klisyri (tirbanibulin), indicated for the topical treatment of actinic keratosis ((AK)) of the face or scalp.The CHMP opinion is based on two phase III studies (KX01-AK-003 and KX01-AK-004) positive results. These two double-blind, vehicle-controlled, randomized, parallel-group, multi-centre phase III clinical trials, which included 702 patients from 62 clinical sites across the US, showed that application of tirbanibulin ointment 1% (10 mg/g) in adults with AK on the face or scalp is effective and well tolerated.Actinic keratosis ((AK)) is a chronic skin disease that occurs primarily in areas that have been exposed to ultraviolet ((UV)) radiation for a long period of time.The approval of Klisyri (tirbanibulin) is expected in about 60 days and its launch in Europe could take place in late 2021, Almirall said

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Athenex says Almirall's klisyri treatment gets positive CHMP opinion