Neuroscience-focused, biopharmaceutical company Neurocrine Biosciences, Inc. announced on Friday the FDA approval of CRENESSITY (crinecerfont) capsules and oral solution for adults and children aged four and older with classic congenital adrenal hyperplasia (CAH).

CRENESSITY, a corticotropin-releasing factor type 1 receptor antagonist, reduces adrenocorticotropic hormone and androgen production, enabling glucocorticoid dose reductions. This marks a significant advancement in CAH treatment.

Commercial availability is expected within a week, with distribution managed through PANTHERx Rare specialty pharmacy for streamlined prescription fulfillment. Neurocrine Access Support provides patients, caregivers, and providers assistance with insurance navigation and financial aid, supported by dedicated Care Coordinators.

FDA approval was based on the CAHtalyst Phase 3 trials, the largest clinical program for CAH, showing CRENESSITY effectively lowers steroid doses and androgen levels in pediatric and adult patients. Key trial results demonstrated substantial reductions in androstenedione and 17-hydroxyprogesterone, alongside improved glucocorticoid management.

Common adverse drug reactions, such as headache and fatigue, were generally mild and temporary. Adrenal insufficiency remains a potential risk, emphasizing the need for careful glucocorticoid management under medical guidance.