The U.S. FDA has approved Neurocrine Biosciences’ capsules and oral solution as 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).
CAH is a rare, serious and lifelong genetic condition involving the adrenal glands. Neurocrine’s treatment, branded Crenessity, is a potent and selective oral corticotropin-releasing factor type 1 receptor (CRF1) antagonist. It is the first and only classic CAH treatment that directly reduces excess adrenocorticotropic hormone (ACTH) and downstream adrenal androgen production, allowing for glucocorticoid dose reduction.
The approval is supported by the CAHtalyst Pediatric and Adult phase 3 global registrational studies. In both studies, Crenessity enabled lower steroid doses and decreased androgen levels.
Neurocrine expects Crenessity to be commercially available in approximately one week. The medication will be provided through PANTHERx Rare, a specialty pharmacy, to centralize and simplify prescription fulfillment.