Resumption of dosing in clinical studies of fitusiran for hemophilia A & B

Alnylam Pharmaceuticals, Inc. the leading RNAi therapeutics company, announced a successful Type A meeting with the FDA where alignment was achieved on safety measures and a risk mitigation strategy to enable resumption of dosing in clinical studies with fitusiran, including the Phase II open-label extension (OLE) study and the ATLAS Phase III program. With the completion of the Type A meeting, the FDA will now consider removal of the clinical hold upon final review of the amended protocols and other trial materials. Fitusiran is an investigational RNAi therapeutic targeting antithrombin (AT) for the treatment of patients with hemophilia A and B, that is designed to lower levels of AT with the goal of promoting sufficient thrombin generation to restore hemostasis and prevent bleeding.