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# FDA Extends Review Date for BioMarin’s Roctavian
- URL: https://www.fdaweb.com/fda-extends-review-date-for-biomarins-roctavian/
- Published: 2023-03-07T12:00:00.000Z
- Updated: 2026-09-14T18:18:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153915

FDA has extended the PDUFA review date for BioMarin’s BLA for Roctavian (valoctocogene roxaparvovec) gene therapy for adults with severe hemophilia A to 6/30\. The agency said it had determined that the company’s submission of the three-year data analysis from the ongoing Phase 3 GENEr8-1 study constituted a major amendment to the BLA due to the substantial amount of additional data.

BioMarin [says](https://investors.biomarin.com/2023-03-06-BioMarin-Provides-Update-on-FDA-Review-of-ROCTAVIAN-TM-Valoctocogene-Roxaparvovec-Gene-Therapy-for-Adults-with-Severe-Hemophilia-A?ref=fdaweb.com) FDA completed a pre-license inspection of the manufacturing facility in early 12/2022\. It granted Roctavian regenerative medicine advanced therapy designation in 3/2021 and breakthrough therapy designation in 2017\. FDA also granted it orphan drug designation.