The following is an edited version of a press release from Alnylam Pharmaceuticals. To read the press in full, click here.
Alnylam completed a successful meeting with the U.S. Food and Drug Administration (FDA), reaching alignment on safety measures and a risk mitigation strategy for clinical studies with fitusiran. These measures include protocol-specified guidelines along with additional education for investigators and patients regarding the use of reduced doses of replacement factor or bypassing agent to treat any breakthrough bleeds while participating in fitusiran clinical studies.
This is an important step in moving the fitusiran clinical program forward. Alnylam is committed to reinitiating the Phase 2 open-label extension study and the Phase 3 ATLAS program around year-end, following final regulatory agency review of the amended protocol and other trial materials.