BioMarin: FDA No Longer Plans To Hold Advisory Committee Meeting To Discuss BLA

BioMarin Pharmaceutical Inc. (BMRN) said the company was recently notified by the FDA that, at this time, the Agency no longer plans to hold an advisory committee meeting to discuss the BLA for ROCTAVIAN that is currently under review for adults with severe Hemophilia A. The FDA granted Regenerative Medicine Advanced Therapy designation to valoctocogene roxaparvovec in March 2021.

The company said it remains on track to host the scheduled FDA Pre-Licensure Inspection of BioMarin's gene therapy manufacturing facility located in Novato, CA.

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