Neurocrine Biosciences Announces Commercial Availability of CRENESSITY™ (crinecerfont) for Children and Adults With Classic Congenital Adrenal Hyperplasia

Core Insights - Neurocrine Biosciences has announced the commercial availability of CRENESSITY™ (crinecerfont) in the United States as an adjunctive treatment for classic congenital adrenal hyperplasia (CAH) in patients aged four years and older [1][9][16] - CRENESSITY has been approved by the U.S. Food and Drug Administration (FDA) to help control androgen levels in patients with CAH, addressing long-standing challenges associated with high-dose steroid treatments [2][7][18] Company Overview - Neurocrine Biosciences is a biopharmaceutical company focused on developing treatments for neurological, neuroendocrine, and neuropsychiatric disorders, with a commitment to providing life-changing therapies for patients with unmet medical needs [28] - The company has a diverse portfolio that includes FDA-approved treatments for various conditions, including CAH, and is dedicated to supporting patients through programs like Neurocrine Access Support [2][28] Product Details - CRENESSITY is a potent and selective oral corticotropin-releasing factor type 1 receptor (CRF1) antagonist that reduces adrenocorticotropic hormone (ACTH) and adrenal androgens, allowing for lower doses of glucocorticoids while maintaining or improving androgen levels [8][16][30] - The product is available in capsule form (50 mg and 100 mg) and as an oral solution (50 mg/mL), with specific dosing recommendations based on patient age and weight [30] Clinical Studies - The approval of CRENESSITY was supported by the CAHtalyst™ global registrational studies, which included the largest-ever clinical trial program for classic CAH, involving 285 pediatric and adult patients [6][7][18][22] - The studies demonstrated that CRENESSITY effectively improved androgen control and allowed for the down-titration of glucocorticoids while maintaining or improving androstenedione levels [22]