Alnylam Pharma Announces FDA's Decision To Lift Clinical Hold On Fitusiran

(RTTNews) - Sanofi Genzyme, global business unit of Sanofi, and Alnylam Pharmaceuticals, Inc. (ALNY) announced the U.S. FDA has lifted the hold on clinical studies with fitusiran, including the Phase 2 open-label extension study and the ATLAS Phase 3 program. Fitusiran is an investigational RNAi therapeutic targeting antithrombin for the treatment of patients with hemophilia A and B.

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. The FDA has now approved the protocol amendments and other updated clinical materials for fitusiran studies.

Sanofi has an alliance with Alnylam Pharma to co-develop and co-commercialize fitusiran in the United States, Canada and Western Europe. In addition, Sanofi has the exclusive right to commercialize fitusiran in the rest of the world.

Akin Akinc, Vice President and General Manager, Fitusiran at Alnylam, said: "With the additional risk mitigation measures in place, we look forward to the continued late-stage development of fitusiran and expect to resume dosing around year-end."