March 10, 2020
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FDA accepts NDA for actinic keratosis ointment

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Almirall announced the FDA accepted a new drug application for tirbanibulin to treat actinic keratosis, according to a press release.

The NDA filing was based on two phase 3 studies that assessed the efficacy and safety of tirbanibulin ointment 1% in 702 adults with actinic keratosis (AK) on the face or scalp. Both studies achieved statistical significance for the primary endpoint of complete clearance of actinic keratosis lesions at day 57.

The FDA’s acceptance for filing of the NDA of tirbanibulin, following the acceptance for filing by the [European Medicines Agency], demonstrates a significant step towards its approval both in the U.S. and Europe,” Volker Koscielny, MD, chief medical officer of Almirall, said in the release.

In 2017, Almirall and Athenex created a strategic partnership to develop and commercialize tirbanibulin in the United States and Europe.

“We are delighted by the FDA’s acceptance for filing of the NDA for tirbanibulin ointment, which was submitted in late December 2019,” Rudolf Kwan, MD, chief medical officer of Athenex, said in the release. “Tirbanibulin is the first compound to come out of Athenex’s discovery program. It marks an important step towards bringing this valuable treatment option to AK patients, and we look forward to working with the FDA during the review process towards potential approval.”