Neurocrine Biosciences Launches CRENESSITY™ for Classic CAH Treatment in the U.S.
Neurocrine Biosciences, Inc. has made waves in the healthcare market with the introduction of its innovative treatment, CRENESSITY™ (crinecerfont), specifically designed for individuals afflicted by classic congenital adrenal hyperplasia (CAH). Officially available in the United States as of December 20, 2024, this novel medication marks a significant advancement in therapy options for both children and adults. The U.S. Food and Drug Administration (FDA) has formally approved CRENESSITY as an adjunct to glucocorticoid replacement therapy aimed at managing androgen levels in patients aged four and older with CAH.
CAH is a rare genetic disorder characterized by enzyme deficiencies that disrupt adrenal hormone production, leading to serious health issues if untreated. CRENESSITY operates as a selective oral antagonist of the corticotropin-releasing factor type 1 receptor (CRF1), directly diminishing the levels of adrenocorticotropic hormone (ACTH) and consequently, adrenal androgens. This approach allows patients to reduce glucocorticoid doses while effectively controlling their androgen levels, representing a groundbreaking shift in treatment protocols that have relied on high-dose steroids for over seven decades.
Kyle W. Gano, Ph.D., CEO of Neurocrine Biosciences, expressed pride in making CRENESSITY available to the CAH community, highlighting the challenges people with this condition have historically faced. To ensure streamlined access, CRENESSITY can only be prescribed through PANTHERx Rare, a specialty pharmacy staffed with pharmacists trained in CAH support, available around the clock to address patients' and caregivers' queries and concerns.
Furthermore, Neurocrine Biosciences extends its support through the Neurocrine Access Support program, providing a complimentary, extensive resource for patients and caregivers as they navigate the complexities of insurance and financial assistance. The program aims to make the transition to CRENESSITY as smooth as possible, with an impressive expectation that 90% of patients will see their monthly copay reduced to $12 or less.
Clinical validation for CRENESSITY was robust, supported by the CAHtalyst™ studies, the most extensive clinical trial program to examine therapies for classic CAH. These trials included both pediatric and adult populations to understand the full spectrum of efficacy and safety. Results demonstrated that patients using CRENESSITY had improved control over their androgen levels, allowing for decreased glucocorticoid treatment without sacrificing hormonal balance.
The introduction of CRENESSITY is lauded as a milestone in the management of CAH, directly addressing the longstanding reliance on high-dose glucocorticoids that have culminated in various adverse side effects. High-dose glucocorticoids are associated with metabolic complications, psychological issues, and significant health risks, particularly among pediatric patients whose growth and development can be profoundly impacted. CRENESSITY presents a safer alternative, potentially transforming the lives of many who battle this condition.
Neurocrine is more than just a pharmaceutical entity; it's on a mission to redefine treatment methodologies in under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. Their commitment to innovative science is exemplified through their dedication to providing effective and safe treatment solutions for CAH. As the availability of CRENESSITY marks a new chapter of hope for CAH patients, the future of treatment promises to ameliorate the long-standing challenges associated with managing this complex disorder.
As we look towards the horizon, the future of CAH treatment continues to evolve with Neurocrine's efforts proving pivotal for those in need. For additional information on CRENESSITY and its implications for CAH treatment, healthcare providers and patients can consult the dedicated resources available at www.nbiaccess.com/crenessity or contact the Neurocrine Access Support hotline at 1-855-CRNSITY (276-7489).
CAH is a rare genetic disorder characterized by enzyme deficiencies that disrupt adrenal hormone production, leading to serious health issues if untreated. CRENESSITY operates as a selective oral antagonist of the corticotropin-releasing factor type 1 receptor (CRF1), directly diminishing the levels of adrenocorticotropic hormone (ACTH) and consequently, adrenal androgens. This approach allows patients to reduce glucocorticoid doses while effectively controlling their androgen levels, representing a groundbreaking shift in treatment protocols that have relied on high-dose steroids for over seven decades.
Kyle W. Gano, Ph.D., CEO of Neurocrine Biosciences, expressed pride in making CRENESSITY available to the CAH community, highlighting the challenges people with this condition have historically faced. To ensure streamlined access, CRENESSITY can only be prescribed through PANTHERx Rare, a specialty pharmacy staffed with pharmacists trained in CAH support, available around the clock to address patients' and caregivers' queries and concerns.
Furthermore, Neurocrine Biosciences extends its support through the Neurocrine Access Support program, providing a complimentary, extensive resource for patients and caregivers as they navigate the complexities of insurance and financial assistance. The program aims to make the transition to CRENESSITY as smooth as possible, with an impressive expectation that 90% of patients will see their monthly copay reduced to $12 or less.
Clinical validation for CRENESSITY was robust, supported by the CAHtalyst™ studies, the most extensive clinical trial program to examine therapies for classic CAH. These trials included both pediatric and adult populations to understand the full spectrum of efficacy and safety. Results demonstrated that patients using CRENESSITY had improved control over their androgen levels, allowing for decreased glucocorticoid treatment without sacrificing hormonal balance.
The introduction of CRENESSITY is lauded as a milestone in the management of CAH, directly addressing the longstanding reliance on high-dose glucocorticoids that have culminated in various adverse side effects. High-dose glucocorticoids are associated with metabolic complications, psychological issues, and significant health risks, particularly among pediatric patients whose growth and development can be profoundly impacted. CRENESSITY presents a safer alternative, potentially transforming the lives of many who battle this condition.
Neurocrine is more than just a pharmaceutical entity; it's on a mission to redefine treatment methodologies in under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. Their commitment to innovative science is exemplified through their dedication to providing effective and safe treatment solutions for CAH. As the availability of CRENESSITY marks a new chapter of hope for CAH patients, the future of treatment promises to ameliorate the long-standing challenges associated with managing this complex disorder.
As we look towards the horizon, the future of CAH treatment continues to evolve with Neurocrine's efforts proving pivotal for those in need. For additional information on CRENESSITY and its implications for CAH treatment, healthcare providers and patients can consult the dedicated resources available at www.nbiaccess.com/crenessity or contact the Neurocrine Access Support hotline at 1-855-CRNSITY (276-7489).
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