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Roctavian FDA Approval Status

Last updated by Judith Stewart, BPharm on July 9, 2020.

FDA Approved: No
Brand name: Roctavian
Generic name: valoctocogene roxaparvovec
Company: BioMarin Pharmaceutical Inc.
Treatment for: Hemophilia A

Roctavian (valoctocogene roxaparvovec) is an investigational gene therapy in development for the treatment of hemophilia A.

Development timeline for Roctavian

DateArticle
Sep 29, 2022BioMarin Resubmits Biologics License Application (BLA) for Valoctocogene Roxaparvovec AAV Gene Therapy for Severe Hemophilia A to the FDA
Mar  8, 2021BioMarin Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to Valoctocogene Roxaparvovec, Investigational Gene Therapy for Hemophilia A
Aug 19, 2020BioMarin Receives Complete Response Letter (CRL) from FDA for Valoctocogene Roxaparvovec Gene Therapy for Severe Hemophilia A
Jun 17, 2020BioMarin Provides Additional Data from Recent 4 Year Update of Ongoing Phase 1/2 Study of Valoctocogene Roxaparvovec Gene Therapy for Severe Hemophilia A in Late-Breaking Oral Presentation at World Federation of Hemophilia Virtual Summit
May 31, 2020BioMarin Provides Highlights of 4 Years of Clinical Data from Ongoing Phase 1/2 Study of Valoctocogene Roxaparvovec Gene Therapy for Severe Hemophilia A
Dec 23, 2019BioMarin Submits Biologics License Application to U.S. Food and Drug Administration for Valoctocogene Roxaparvovec to Treat Hemophilia A
Oct 26, 2017FDA Grants Breakthrough Therapy Designation for BioMarin's Valoctocogene Roxaparvovec (formerly BMN 270), an Investigational Gene Therapy for Hemophilia A

Further information

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