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FDA Accepts OCA NASH NDA; Palatin Initiates Ph2b DKD Trial
Two cardiometabolic-related news items have been observed: Intercept announced FDA has accepted the NDA for obeticholic acid (OCA) seeking accelerated approval for the treatment of patients with pre-cirrhotic liver fibrosis due to NASH (view press release); and Palatin Technologies announced that its Ph2b BREAKOUT study (CT.gov record not observed), evaluating melanocortin agonist bremelanotide in DKD, initiated enrollment in December 2022 (view press release). Below, FENIX provides highlights and insights for the respective news items, including commentary on the future of OCA’s NASH indication.