FDA Approves New Drug for Control of Androgens.

The USFDA has approved Neurocrine Biosciences’ new drug, Crenessity (Crinecerfont), for the treatment of classic congenital adrenal hyperplasia (CAH). Crinecerfont is an adjunctive treatment to glucocorticoid replacement to control androgens in adult and pediatric patients.

CAH is a rare genetic condition where the adrenal glands do not produce enough cortisol and produce too many androgens. To compensate for the deficient cortisol, patients require high doses of steroids (glucocorticoids), which impact quality of life. Crenessity reduces excessive adrenal androgen production, allowing for glucocorticoid dose reduction.

In a press statement Neurocrine Biosciences claimed that FDA approval of Crinecerfont is supported by data from the largest-ever clinical trial program in patients with classic CAH. Crenessity’s approval is based on two randomized, double-blind, placebo-controlled trials in 182 adults and 103 children with classic CAH. FDA had granted Crenessity  Fast Track, Breakthrough Therapy, Orphan Drug and Priority Review designations.

Crenessity is available in two dosage forms as capsules and oral solution. Capsule formulation available in 50 mg and 100 mg doses and oral solution as a 50 mg/mL strength formulation. As per Neurocrine treatment with CRENESSITY will cost $10 or less per month for most patients

Neurocrine Press statement