FDA Approves Sarepta's Duchenne Therapy for Younger Patients Amid Ongoing Investigations
TL;DR Summary
The FDA has allowed Sarepta Therapeutics to resume shipments of its Duchenne muscular dystrophy gene therapy, Elevidys, for younger patients who can walk, after a brief halt due to safety concerns related to non-ambulatory patients following two deaths. The agency continues to review the therapy for non-ambulatory patients, where a voluntary hold remains in effect.
- FDA permits use of Sarepta Therapeutics’ Duchenne therapy in younger patients after short-lived halt statnews.com
- Sarepta resumes shipping of gene therapy Elevidys to patients who can walk CNBC
- Opinion | The Sarepta Mugging and Drug Innovation The Wall Street Journal
- FDA Says Sarepta (SRPT) Can Treat Ambulatory Patients With Gene Therapy Elevidys Bloomberg.com
- FDA launches probe into new Elevidys death as Sarepta, Roche stress gene therapy not at fault Fierce Pharma
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