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FDA Approves New Treatment for Congenital Adrenal Hyperplasia (CAH)
The U.S. Food and Drug Administration approved Crenessity (crinecerfont) to be used together with glucocorticoids (steroids) to control androgen (a testosterone-like hormone) 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 (more than is typically needed to replace the deficient cortisol) 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 has a warning for acute adrenal insufficiency or adrenal crisis, which can occur if patients with underlying adrenal insufficiency who do not also receive adequate doses of glucocorticoid replacement therapy in situations associated with increased cortisol need (i.e., “stress dose steroids”). Crenessity should not be taken by patients with hypersensitivity to Crenessity’s active ingredient or any of its components.
Because Crenessity is metabolized by a specific enzyme, using Crenessity at the same time as drugs that activate that enzyme can decrease the amount of Crenessity exposure and reduce Crenessity’s efficacy. Information about recommended dose adjustments is included in Crenessity’s full prescribing information.
The most common side effects of Crenessity in adults include fatigue, dizziness and arthralgia (joint pain). For pediatric patients, the most common side effects are headache, abdominal pain and fatigue.
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