Sarepta’s Next-Generation Drugs Draw Attention Amid ‘Incremental’ Approval
Amondys 45 Gets DMD Nod From FDA
The RNA drug’s accelerated approval brings Sarepta’s exon-skipping market share to nearly 30%.
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The company plans to start its Phase III trial of SRP-9001 in the middle of this year, with a potential readout by the end of 2022.
Any time advantage Sarepta's Duchenne muscular dystrophy gene therapy may have had over rivals, notably Pfizer, has disappeared after SRP-9001 failed to significantly improve muscle function in a closely watched trial.
Durable responses have continued to be seen two years after administration of Sarepta’s candidate gene therapy to four boys with Duchenne muscular dystrophy.