BioCentury
ARTICLE | Regulation

BioMarin’s vosoritide clears regulatory hurdle as FDA sets goal date

November 3, 2020 6:58 PM UTC

Although BioMarin’s NDA for its achondroplasia treatment doesn’t quite match up with an FDA advisory committee’s recommendation for review, the agency has accepted the biotech’s application and set a PDUFA date of Aug. 20, 2021.

FDA’s action removes some uncertainty as to whether the dataset from BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) would be sufficient for a review of vosoritide, the company’s CNP analog, or whether a refusal-to-file letter was possible. The therapy received standard review to treat achondroplasia, a form of dwarfism...

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