…………. catching up on recent FDA approvals
The FDA recently approved a new therapy, Crenessity (crinecerfont) from Neurocrine Biosciences, Inc., to be used together with glucocorticoids (steroids) to control androgen levels in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia (CAH).
Classic congenital adrenal hyperplasia is a rare genetic condition affecting the adrenal glands, which produce hormones such as cortisol and androgens. Patients with classic CAH do not produce enough cortisol and produce too many androgens. These patients require high doses of glucocorticoids because the glucocorticoids also help to reduce the excess levels of androgens. Crenessity works by reducing excessive adrenal androgen production, which helps reduce the amount of glucocorticoid treatment needed.
Crenessity was granted an Orphan Drug designation. The estimated prevalence of CAH is 1/10,000. Annual incidence ranges from 1/5,000 to 1/15,000.
Dosing for adults on therapy are 2 capsules daily. Crenessity is also available as an oral solution for children who are dosed based on weight.
Neurocrine has set the US list price for Crenessity at approximately $38,333 for a 30-day supply for adults ($460,000 annually). For pediatric patients weighing less than 20 kilograms, the 30-day supply is priced at about $19,167 ($230,000annually).
Crenessity is available through limited distribution. PantherRx Rare Specialty Pharmacy has confirmed that they were selected as a limited distribution partner.
CLICK HERE to access prescribing information
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