Massachusetts-based Alnylam Pharmaceuticals, an affiliate of health care solution developer Sanofi currently taking a lead role in a clinical development program addressing hemophilia, recently revealed an adverse event in relation to its investigational treatment fitusiran.
Citing “a fatal thrombotic event” in a patient with hemophilia A enrolled in a Phase 2 study, Alnylam has suspended use of the product in all existing fitusiran studies pending additional review, a release from Sanofi's Genzyme Corp. said.
The company said subsequent to compliance with all necessary measures, it expects to continue its work with fitusiran, an RNAi therapeutic planned as a therapy for hemophilia A and B with or without inhibitors. Sanofi has an agreement with Alnylam to jointly develop and market the medication.
“Based on overall consideration of fitusiran’s benefit-risk profile, Alnylam aims to resume dosing as soon as it is feasible upon agreement with global regulatory authorities and with appropriate protocol amendments for enhanced patient safety monitoring in place,” the release said.