> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Priority Review for BioMarin’s Vosoritide
- URL: https://www.fdaweb.com/priority-review-for-biomarins-vosoritide/
- Published: 2021-04-15T12:00:00.000Z
- Updated: 2026-09-14T16:55:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149122

FDA has granted priority review status to a BioMarin NDA for vosoritide, an analog of C-type natriuretic peptide in children with achondroplasia, described as the most common form of short stature in humans. The agency granted priority review based on the serious pediatric indication the drug addresses, BioMarin says. It [says](https://investors.biomarin.com/2021-04-15-BioMarin-Announces-New-and-Updated-Data-at-2021-American-College-of-Medical-Genetics-and-Genomics-ACMG-Annual-Clinical-Genetics-Meeting-Demonstrating-Commitment-to-Understanding-Achondroplasia-and-Potential-Treatment-Choice?ref=fdaweb.com) the designation will not affect the target PDUFA action date of 8/20.

However, it says, the company has chosen to provide the two-year outcomes from the Phase 3 extension study to FDA as additional data to convey the vosoritide treatment effect and long-term durability. BioMarin says the additional data could result in a major amendment, which could extend the PDUFA date to 11/20.