Neurocrine Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) approved CRENESSITY (crinecerfont) capsules and oral solution. This approval is for an adjunctive treatment to glucocorticoid replacement to control androgens in adult and pediatric patients four years of age and older with classic congenital adrenal hyperplasia (CAH).
CRENESITY is a potent and selective oral corticotropin-releasing factor type 1 receptor (CRF1) antagonist, representing the first and only classic CAH treatment that directly reduces excess adrenocorticotropic hormone (ACTH) and downstream adrenal androgen production. This mechanism allows for glucocorticoid dose reduction, marking a breakthrough in the treatment landscape for classic CAH.
The FDA approval was supported by the CAHtalyst Pediatric and Adult Phase 3 global registrational studies, which constituted the largest-ever clinical trial program for classic CAH, involving 285 pediatric and adult patients. CRENESSITY is expected to be commercially available in approximately one week through PANTHERx Rare, a specialty pharmacy.
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