Neurocrine’s Crenessity (Crinecerfont) Secures the US FDA’s Approval to Treat Adults and Pediatrics with Congenital Adrenal Hyperplasia (CAH)
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The US FDA’s approval of Crenessity as an adjunctive treatment to glucocorticoid replacement to treat CAH was based on a global P-III (CAHtalyst Pediatric: n=103, age: 4-17yrs. & Adult: n=182, age: 18-58yrs.) trials. It has also received PRV on approval
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Pediatric study achieved its 1 & 2EP, depicting ~4x greater reductions in androstenedione at wk.4 & GC doses (with improved androgen levels) at wk.28 as well as ~12x greater reduction in 17-OHP vs PBO
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Adult study also met its 1 & 2EP, showing 63% vs 18% (PBO) achieving physiologic GC doses with ~2x greater steroid dose reduction at wk.24, ~8x greater reduction in androstenedione levels at wk.4 and ~37x greater reduction in 17-OHP vs PBO
Ref: PRNewswire | Image: Neurocrine Biosciences
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