The Food and Drug Administration (FDA) has issued a priority review voucher to the sponsor of the rare pediatric disease product, CRENESSITY (crinecerfont). This voucher is awarded under the Federal Food, Drug, and Cosmetic Act, which allows such recognition for approved products meeting specific criteria. CRENESSITY is manufactured by Neurocrine Biosciences, Inc., and was approved on December 13, 2024, for the treatment of classic congenital adrenal hyperplasia in adults and children aged four and older. This announcement fulfills FDA's requirement to publish notice of such awards.
Simple Explanation
The FDA gave a special ticket to a medicine called CRENESSITY that helps children with a rare illness so it could be checked faster, and they had to tell everyone they did this.