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,”

Endpoints News

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.