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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As rival Phase III gene therapy trials get underway, Sarepta’s product could have the edge in safety and efficacy over its rival from Pfizer, but the chance of failure remains high.
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.