Posted by Michael Wonder on 16 Sep 2019
Wave Life Sciences announces fast track designation from U.S. FDA for suvodirsen
16 September 2019 - Suvodirsen is an investigational stereopure oligonucleotide in development for the treatment of DMD patients amenable to exon 51 skipping.
Wave Life Sciences today announced that the U.S. FDA has granted fast track designation to suvodirsen for the treatment of Duchenne muscular dystrophy (DMD) in patients amenable to exon 51 skipping. The designation was based on comprehensive in vitro and in vivo non-clinical data that support the potential for suvodirsen to address a significant unmet medical need.
Suvodirsen has also been granted orphan drug designation for the treatment of DMD by the FDA and the European Commission, as well as rare paediatric disease designation by the FDA.
