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.
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