Update: FDA lifts suspension of Fitusiran trial

The United States Food and Drug Administration has agreed to allow Alnylam’s clinical trial of the novel drug Fitusiran to resume. The FDA and Alnylam have agreed on new risk mitigation measures, including revised trial guidelines and additional investigator and patient education regarding the use of reduced doses of clotting factor concentrates or bypassing agents to treat breakthrough bleeds while participating in fitusiran clinical studies. The company expects the trial to resume shortly.
To see the original WFH article and the Alnylam press release please click here.