Kuvan Receives Priority Review Status From FDA

BioMarin Pharmaceutical announced that the FDA accepted for filing, and granted priority review status to, the new drug application for Kuvan.

BioMarin said it expects the FDA to take action on the Kuvan (sapropterin dihydrochloride ) application by November 25.

Kuvan, an investigational oral small molecule for the treatment of phenylketonuria, a rare genetic metabolic disorder, is being developed in partnership with Merck Serono, a division of Merck KGaA, the company added.