Neurocrine Biosciences Gets FDA Priority Review for Crinecerfont

By Colin Kellaher

Neurocrine Biosciences has won Food and Drug Administration priority review of its proposed treatment for the rare genetic endocrine disorder congenital adrenal hyperplasia, or CAH.

Neurocrine on Monday said the FDA has set target action dates in late December for its decision on a pair of applications seeking approval of crinecerfont in the treatment of children, adolescents and adults with classic CAH.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period.

The San Diego biopharmaceutical company said an FDA green light would make crinecerfont the first new treatment option for CAH in 70 years.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

July 01, 2024 08:09 ET (12:09 GMT)

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