On July 29th, Roche announced its readiness to immediately resume new orders and shipments of Elevidys for ambulatory patients outside the United States. This follows the FDA’s recommendation to lift the temporary pause on shipments for ambulatory individuals with Duchenne muscular dystrophy.
Based on a comprehensive review of the available data, Roche maintains that the benefit-risk profile of Elevidys remains positive in the ambulatory patient population. Roche continues to prioritise patient safety above all else.
The full community letter can be read here
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