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Crenessity to receive major safety-related recall or warning by end of 2025?
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FDA announcements and Neurocrine Biosciences press releases
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FDA Approves Neurocrine Biosciences' Crenessity, First New Treatment for CAH in 70 Years
Dec 13, 2024, 08:13 PM
The U.S. Food and Drug Administration (FDA) has approved Neurocrine Biosciences' Crenessity (crinecerfont) for the treatment of adults and pediatric patients over 4 years of age with classic congenital adrenal hyperplasia (CAH). This approval marks the first new treatment option for CAH in 70 years, offering a paradigm-shifting approach by directly reducing excess adrenocorticotropic hormone (ACTH) and downstream adrenal androgen production, allowing for glucocorticoid dose reduction. The approval was supported by data from the largest-ever clinical trial program in pediatric and adult patients with classic CAH. Crenessity is expected to be commercially available in approximately one week.
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