Chugai implements safety measures for Elevidys
Japanese drugmaker Chugai (TYO: 4519) announced that it has implemented measures based on safety evaluations for Elevidys intravenous infusion (delandistrogene moxeparvovec), a regenerative medical product for Duchenne muscular dystrophy (DMD) discovered by Sarepta Therapeutics (Nasdaq: SRPT) and in-licensed Roche (ROG: SIX), the majority owner of Chugai, which also passed rights to the drug to the Japanese firm.
In Japan, Elevidys obtained regulatory approval from the Ministry of Health, Labor and Welfare (MHLW) under the conditional and time-limited approval pathway for ambulatory DMD patients aged 3 to under 8 years on May 13, 2025. Following two reports of acute liver failure with fatal outcomes in non-ambulatory DMD patients who were treated with Elevidys overseas, we have been in discussion with MHLW and the Pharmaceuticals and Medical Devices Agency (PMDA) regarding safety measures for this product.
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