NEUROCRINE BIOSCIENCES, INC.

Crinecerfont (Crenessity) received FDA approval for classic congenital adrenal hyperplasia (CAH), the first new treatment in 70 years. It reduces adrenal androgen production, allowing lower glucocorticoid doses, with demonstrated efficacy and safety in pediatric and adult studies.

Neurocrine Biosciences' Crenessity (crinecerfont) receives FDA approval, marking the first new CAH treatment in 70 years. This oral therapy addresses a treatment gap for CAH, a life-threatening endocrine disorder affecting 30,000 in the U.S. Crenessity reduces glucocorticoid dosage, controlling ACTH overproduction and offering a safer alternative to steroid treatments.

The schizophrenia market in 7MM is projected to grow at a 7.4% CAGR, from $8.4b in 2021 to $17b in 2031, driven by 11 late-stage pipeline products. These therapies are expected to capture 33.4% of the market share in 2031, with Cobenfy projected to be the top-selling drug by 2031, with $2.2b in sales. However, patent expirations of LAIs may slow growth, though new therapies will help counterbalance this.

Neurocrine Biosciences' new FDA-approved non-steroidal drug, Crenessity, treats classic congenital adrenal hyperplasia (CAH), offering an alternative to steroid treatments with fewer side effects. Approved for both adults and children aged 4+, it reduces ACTH and adrenal androgens, with potential for significant revenue. Neurocrine plans to disclose pricing upon launch, with projections of $150 million in 2025 and peak sales of $1.47 billion.

Neurocrine to launch Crenessity, the first new drug for congenital adrenal hyperplasia in 70 years, for adults and children, with pricing to be announced soon.

FDA approves crinecerfont (Crenessity) for classic congenital adrenal hyperplasia (CAH), a rare genetic condition affecting adrenal glands. It reduces adrenal androgen overproduction, allowing lower glucocorticoid doses. Trials showed significant reductions in androstenedione levels and glucocorticoid doses in both adults and children. Common side effects include tiredness, dizziness, and muscle pain. Available in capsules and oral solution via PANTHERx Rare.

FDA approves Neurocrine's Crenessity for classic congenital adrenal hyperplasia, marking the first targeted treatment. Crenessity reduces excess adrenocorticotropic hormone and adrenal androgen production, allowing glucocorticoid dose reduction. Analysts see blockbuster potential, emphasizing patient and clinician education for market success.

Neurocrine Biosciences announced FDA approval of Crenessity (crinecerfont) for classic congenital adrenal hyperplasia (CAH), reducing excess adrenal androgens and enabling glucocorticoid dose reduction. Crenessity is the first CAH treatment directly targeting ACTH and adrenal androgen production. Phase 3 CAHtalyst studies showed significant steroid dose reductions and decreased androgen levels in both pediatric and adult patients, with few treatment-related adverse events.

The schizophrenia market in 7MM is expected to grow at a CAGR of 7.4% from $8.4bn in 2021 to $17bn in 2031, driven by 11 late-stage pipeline products. These new products, with higher annual cost of therapy, will capture 33.4% of global sales in 2031. Cobenfy, approved in 2024, could become the top-selling drug with $2.2 billion sales in 2031. The US dominates the market due to a large patient population and high drug costs. Challenges include generic erosion of antipsychotic LAIs, but pipeline therapies will fuel market growth.

Mon, December 16, 2024 at 3:05 PM UTC, 3 min read.