Chugai gains Japanese approval for Elevidys to treat DMD

Japanese drugmaker Chugai Pharmaceutical (TYO: 4519) has obtained regulatory approval from the domestic regulator for Elevidys Intravenous Infusion (delandistrogene moxeparvovec) as a regenerative medicine product for the treatment of Duchenne muscular dystrophy (DMD) under the conditional and time-limited approval pathway.

Chugai licensed the drug from its majority owner, Swiss pharma giant Roche (ROG: SIX), in 2021.

The approved patient population are ambulatory patients with DMD who do not have a deletion of any portion or the entirety of exon 8 and/or exon 9 in the DMD gene, are negative for anti-AAVrh74 antibodies, and are three years to less than eight years of age.