Sarepta Therapeutics Announces Approval in Japan of ELEVIDYS, a Gene Therapy to Treat Duchenne Muscular Dystrophy

ELEVIDYS is approved for individuals ages 3- to less than 8-years-old, who do not have any deletions in exon 8 and/or exon 9 in the DMD gene, and who are negative for anti-AAVrh74 antibodies. This is the first global approval to include individuals younger than 4 years of age.

People aged 3 to under 8 who do not have deletions in exons 8 and/or 9 of the DMD gene and who test negative for anti-AAVrh74 antibodies are eligible to use ELEVIDYS. This is the first worldwide approval that covers people under the age of four.

Learn More: Frequently Asked Questions About Elevidys Used for Duchenne Muscular Dystrophy

ELEVIDYS Gene Therapy Approved in Japan

Sarepta Therapeutics, the leader in precision genetic medicine for rare diseases, today announced that the Japanese Ministry of Health, Labour, and Welfare (MHLW) has approved ELEVIDYS (delandistrogene moxeparvovec) for the treatment of Duchenne muscular dystrophy (DMD) under the conditional and time-limited approval pathway in Japan.

Read More: Will Elevidys Receive Approval from the European Medicines Agency (EMA)?

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