Fitusiran studies to recommence

Sanofi Genzyme, the specialty care global business unit of Sanofi, and Alnylam Pharmaceuticals, Inc. announced that the FDA has lifted the hold on clinical studies with fitusiran, including the Phase II open-label extension (OLE) study and the ATLAS Phase III program.

Alnylam and the FDA had previously reached alignment on new clinical risk mitigation measures, including protocol-specified guidelines and additional investigator and patient education concerning reduced doses of replacement factor or bypassing agent to treat any breakthrough bleeds in fitusiran studies. FDA has now approved the protocol amendments and other updated clinical materials for fitusiran studies.