Sanofi ac­cepts a lengthy de­lay as its he­mo­phil­ia drug fi­tusir­an re­sumes a PhI­II af­ter safe­ty fears forced a halt

Sanofi is get­ting a big part of its late-stage clin­i­cal pro­gram for fi­tusir­an back on track af­ter work­ing out an agree­ment with the FDA on a new set of pro­to­cols. They’re get­ting back in­to the clin­ic with adult and ado­les­cent pa­tients.

But it’s go­ing to cost them a con­sid­er­able amount of time. In a state­ment sent to End­points News, the phar­ma gi­ant says the re­vised ef­fort will de­lay sub­mis­sions by up to about 18 months as re­searchers ad­just to the new guide­lines with al­tered dos­ing.

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