FDA accepts NDA for tirbanibulin in actinic keratosis

Hot on the heels of similar action by the European Medicines Agency, the US Food and Drug Administration has completed its filing review and determined that the New Drug Application (NDA) for tirbanibulin, also known as ALM14789, for the treatment of actinic keratosis (AK), is sufficiently complete to permit a substantive review.

Additionally, the FDA has communicated that it is not currently planning on holding an advisory committee to discuss the application, says the drug’s developer, Spanish dermatology specialist Almirall (ALM: MC), whose shares were down more than 4% at 11.21 euros by close of trading Monday, a day that markets around the world were plunging on coronavirus woes.

“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 US and Europe. We are pleased that our partnership with Athenex continues to be very positive,” commented Almirall’s chief medical officer Dr Volker Koscielny.