Posted by Michael Wonder on 13 Mar 2018
Lumasiran granted breakthrough therapy designation by the United States FDA
12 March 2018 - Alnylam Pharmaceuticals announced today that Sanofi Genzyme has declined its opt-in for the development and commercialisation of lumasiran, an investigational RNAi therapeutic for the treatment of primary hyperoxaluria Type 1.
Based on this decision, Alnylam intends to rapidly advance lumasiran into a Phase 3 pivotal study in late 2018, and to commercialise lumasiran globally, assuming product approval.
In addition, the Company also announced that lumasiran has been granted breakthrough therapy designation by the U.S. FDA, representing the third breakthrough therapy designation the Company has received to date for programs in its pipeline.
