The FDA has reviewed and accepted the New Drug Application (NDA) from Almirall, SA for tirbanibulin, also known as ALM14789, for the treatment of actinic keratosis (AK). The FDA also communicated that it is not currently planning on holding an advisory committee to discuss the application. 

The filing is based on the analysis of two Phase 3 studies (KX01-AK-003 and KX01-AK-004) that evaluated the efficacy and safety of tirbanibulin ointment 1% in adults with actinic keratosis on the face or scalp. Tirbanibulin met the primary endpoint of complete clearance of actinic keratosis lesions at day 57 within the face or scalp treatment areas, achieving statistical significance in each study.

“The FDA’s acceptance for filing of the NDA of tirbanibulin, following the acceptance for filing by the EMA, demonstrates a significant step towards its approval both in the US and Europe. Tirbanibulin has the potential to provide a significant improvement of the quality of life of the patients suffering from actinic keratosis. We are looking forward to continuing to work to prepare for the potential commercial launch of tirbanibulin for AK in the U.S. and Europe. We are pleased that our partnership with Athenex continues to be very positive,” commented Volker Koscielny, MD, Chief Medical Officer of Almirall, in a statement. 

Almirall and Athenex, Inc. entered into a strategic partnership in December 2017 to further develop and commercialize tirbanibulin for the treatment of actinic keratosis and other skin conditionsin the United States and Europe, including Russia. Athenex is responsible for conducting all preclinical and clinical studies up to first FDA approval. Almirall will employ its expertise to support development in Europe and also to commercialize the product in the licensed territories. It is estimated that peak sales of tirbanibulin will be in excess of €250 million.