2 March 2020 - Athenex provided an update today that its partner, Almirall, announced that the EMA has accepted the filing of the marketing authorisation application for tirbanibulin ointment for the treatment of actinic keratosis.

The EMA filing is based on the analysis of two Phase III studies (KX01-AK-003 and KX01-AK-004) conducted in the U.S. that evaluated the efficacy and safety of tirbanibulin ointment 1% (10 mg/g) in adults with actinic keratosis on the face or scalp, as well as clinical, preclinical and CMC data generated by Athenex, included in nine clinical studies.

Athenex and Almirall entered into a license agreement in which Athenex granted Almirall an exclusive license to research, develop and commercialise tirbanibulin ointment in the U.S. and European countries, including Russia. Almirall will employ its expertise to support the development in Europe and commercialise the product in the defined territories.

Read Athenex press release