LEO Pharma announces FDA acceptance of dersimelagon NDA with Priority Review and closes acquisition from Tanabe Pharma18.9.2026 09:00:00 CEST | LEO Pharma | Pressemeddelelse
The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for dersimelagon for filing and granted it Priority Review, with a Prescription Drug User Fee Act (PDUFA) date expected by the end of February 2027. LEO Pharma has successfully closed the acquisition of dersimelagon from Tanabe Pharma, strengthening its late-stage pipeline and further leveraging its global dermatology platform. Dersimelagon is an investigational, once-daily oral melanocortin 1 receptor (MC1R) agonist for the treatment of erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP), two rare genetic skin diseases with significant unmet medical need.