Neurocrine announces FDA accepted two NDAs

Neurocrine Biosciences announced the U.S. Food and Drug Administration, FDA, has accepted its two New Drug Applications , NDA, with Priority Review designations for crinecerfont in the treatment of children, adolescents and adults with classic congenital adrenal hyperplasia, CAH. If approved, crinecerfont would be the first new treatment option for CAH in 70 years and a first-in-class therapy, with a novel approach for the treatment of this rare and serious endocrine disorder. The submitted crinecerfont NDAs included: the primary presentation of efficacy and safety of crinecerfont for the treatment of classic CAH as a capsule formulation; and as an oral solution formulation. The agency set Prescription Drug User Fee target action dates of December 29 and December 30, 2024, respectively.