Posted by Michael Wonder on 26 Mar 2018
Alnylam receives EMA PRIME designation for accelerated assessment of lumasiran, an investigational RNAi therapeutic for the treatment of primary hyperoxaluria type 1
26 March 2018 - Company intends to advance lumasiran to a Phase 3 study in late 2018.
Alnylam Pharmaceuticals announced today that the EMA has granted access to its Priority Medicines (PRIME) scheme for lumasiran (ALN-GO1), an investigational RNAi therapeutic targeting glycolate oxidase for the treatment of primary hyperoxaluria Type 1.
Lumasiran was recently granted breakthrough therapy designation by the United States FDA.
