Alnylam and Sanofi cleared to resume hemophilia candidate trials

The US Food and Drug Administration has lifted the hold on clinical studies with fitusiran, including the Phase II open-label extension (OLE) study and the ATLAS Phase III program.

The clinical hold was imposed in September after reports of a fatal thrombotic event in a patient with hemophilia A without inhibitors in the Phase II open-label extension (OLE) study of fitusiran was reported by the drug’s developer, US RNAi specialist Alnylam Pharmaceuticals (Nasdaq: ALNY).

The news came just 10 months after Sanofi Genzyme, a unit of French pharma major Sanofi (Euronext: SAN) elected to opt in to co-develop and co-commercialize fitusiran for the treatment of hemophilia and rare bleeding disorders (RBD) in the USA, Canada and Western Europe, paying Alnylam $100 million, under its 2014 deal worth a potential $700 million.