On Friday, the FDA approved Neurocrine Biosciences, Inc.(NASDAQ:NBIX) Crenessity (crinecerfont) capsules and oral solution as an adjunctive treatment to glucocorticoid replacement to control androgens in adult and pediatric patients four years of age and older with classic congenital adrenal hyperplasia (CAH). CAH is a rare, inherited disorder that affects the adrenal glands and causes them to be larger than normal. The adrenal glands are locate…

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Neurocrine's Drug Gains FDA Nod As First Targeted Treatment For Certain Type Of Inherited Disorder, Analyst Highlights Blockbuster Potential - Neurocrine Biosciences (NASDAQ:NBIX)

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WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has approved Crenessity (crinecerfont) for use alongside glucocorticoids in managing classic congenital adrenal hyperplasia (CAH) in patients aged four and older. This marks a significant advancement for a rare genetic condition that affects hormone production and poses long-term health challenges. Classic CAH impacts the adrenal glands, leading to insufficient cortisol production an…

MyChesCo

FDA Approves Crenessity for Treating Classic Congenital Adrenal Hyperplasia

(MedPage Today) -- The FDA approved crinecerfont (Crenessity) as a first-in-class treatment for classic congenital adrenal hyperplasia (CAH), the agency announced late Friday.
Crinecerfont was approved for use in combination with glucocorticoids...

MedPage Today

FDA Approves First Drug for Classic Congenital Adrenal Hyperplasia in 70 Years

Neurocrine Biosciences’ Crenessity is now FDA approved for treating classic congenital adrenal hyperplasia (CAH), a rare and potentially fatal endocrine disorder. The approval comes with a priority review voucher, which Neurocrine could sell for around $150 million.  The post Neurocrine Lands FDA Nod for First New Treatment in Decades for Rare Endocrine Disorder appeared first on MedCity News.

MedCity News

Neurocrine Lands FDA Nod for First New Treatment in Decades for Rare Endocrine Disorder

The FDA has approved crinecerfont (Crenessity™) for the treatment of classic congenital adrenal hyperplasia (CAH). The post 70 Years Later, a New Hope: FDA Approves Crinecerfont for CAH appeared first on Rare Disease Advisor

Rare Disease Advisor

70 Years Later, a New Hope: FDA Approves Crinecerfont for CAH

Neurocrine Biosciences has received FDA approval for a new therapy called Crenessity for congenital adrenal hyperplasia (CAH). CAH is an inherited disorder affecting cortisol production, leading to hormone imbalances that can be fatal. Crenessity is a non-steroidal drug that blocks hormone secretion and reduces the need for high doses of steroids, which have many side effects. The drug is approved for adults and children and is expected to be pr…

Dataemia

A turbulent 2024 for Neurocrine is ending on a high note, after the biotech won FDA approval to treat congenital adrenal hyperplasia, a condition marked by adrenal gland dysfunction.
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Endpoints News

Neurocrine gets FDA go-ahead to treat rare adrenal gland condition

The decision is based on positive results from the CAHtalyst trials, which both met their primary and secondary end points.

Pharmacy Times

FDA Approves Crinecerfont for Adult, Pediatric Patients with Congenital Adrenal Hyperplasia

Neurocrine Bioscience's Crenessity is the first new option for classic congenital adrenal hyperplasia (CAH) in more than 70 years

Pharmaphorum

FDA clears Neurocrine drug for rare adrenal disorder

Neurocrine Biosciences, Inc. has received FDA approval for Crenessity (crinecerfont), marking a major breakthrough for CAH treatment. This first-in-class oral therapy addresses a 70-year treatment …   Neurocrine’s First New CAH Treatment in 70 Years Gets FDA Approval Read More » The post Neurocrine’s First New CAH Treatment in 70 Years Gets FDA Approval appeared first on GeneOnline News.

Neurocrine's Drug Gains FDA Nod As First Targeted Treatment For Certain Type Of Inherited Disorder, Analyst Highlights Blockbuster Potential - Neurocrine Biosciences (NASDAQ:NBIX)

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