FDA Reviews Safety of Sarepta's Elevidys Amid Ongoing Concerns
TL;DR Summary
Sarepta Therapeutics issued a statement clarifying that the recent death of an eight-year-old Duchenne muscular dystrophy patient in Brazil, who received their gene therapy ELEVIDYS, was deemed unrelated to the treatment. The FDA is investigating the case, but Sarepta emphasizes their commitment to patient safety and regulatory transparency, highlighting the safety profile and risks associated with ELEVIDYS, including infusion reactions and liver injury.
Topics:business#duchenne-muscular-dystrophy#elevidys#fda-investigation#gene-therapy#healthcare#sarepta-therapeutics
- Sarepta Therapeutics Provides Clarifying Statement on ELEVIDYS Sarepta Therapeutics
- The crisis over Sarepta’s Duchenne therapy is a mess. But the lesson is clear statnews.com
- FDA probes death of patient on Sarepta's Elevidys, partner Roche says death unrelated to therapy Reuters
- 'We will crack gene therapy': Elevidys fallout doesn't dent Roche's hopes for modality Fierce Biotech
- FDA weighs new study requirements for Sarepta to confirm safety of gene therapy Elevidys: report Fierce Pharma
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