Posted by Michael Wonder on 03 Feb 2020
Alnylam receives positive CHMP opinion for Givlaari (givosiran) for the treatment of acute hepatic porphyria in adults and adolescents
31 January 2020 - Positive opinion is based on data from the pivotal ENVISION Phase 3 study.
Alnylam Pharmaceuticals today announced that the CHMP of the EMA has adopted a positive opinion recommending approval of givosiran, an RNAi therapeutic targeting aminolevulinic acid synthase 1 for the treatment of acute hepatic porphyria in adults and adolescents aged 12 years and older.
If approved by the European Commission, givosiran will be commercialised under the brand name Givlaari.
