FDA delays review of BioMarin's hemophilia gene therapy after data update
The FDA has extended its review of BioMarin’s gene therapy for hemophilia A by three months, formalizing an expected delay that will now push out a decision to the end of June.
BioMarin told investors in November, after submitting three-year data analysis from a Phase III trial, that the FDA said it may constitute a major amendment that warrants extra time for review.
And that’s exactly what happened, with the agency citing “substantial amount of additional data,”
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.