FDA accepts BridgeBio's NDA for encaleret to treat ADH1, with approval decision due May 2027

BridgeBio Pharma announced the FDA has accepted its New Drug Application for encaleret, a potential first-ever approved treatment for autosomal dominant hypocalcemia type 1 (ADH1). The FDA's target decision date is May 8, 2027, and the drug showed strong efficacy and safety in trials without needing calcium or vitamin D supplements. BridgeBio is also advancing studies for pediatric ADH1 and chronic hypoparathyroidism, aiming to expand encaleret's use. Approval would mark a major breakthrough for ADH1 patients who currently lack indicated therapies.