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Wave Life Sciences' Duchenne therapy gets US FDA fast-track status

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Wave Life Sciences Ltd. said the U.S. Food and Drug Administration granted fast-track designation to suvodirsen for treating Duchenne muscular dystrophy.

Duchenne muscular dystrophy, or DMD, is a rare genetic disorder characterized by progressive muscle degeneration and weakness. The disease is caused by an absence of dystrophin, a protein that helps keep muscle cells intact.

The Singapore-based biotechnology company is evaluating suvodirsen in an ongoing open-label extension study for DMD patients amenable to skipping of the exon 51 of the dystrophin gene.

Wave Life Sciences anticipates to file for an accelerated approval of suvodirsen in the U.S. in the second half of 2020.

Both the U.S. FDA and the European Commission have granted orphan-drug designation to suvodirsen in treating DMD. The investigational therapy has also received a rare pediatric disease designation from the FDA.