India, May 13 -- Sarepta Therapeutics, Inc. (SRPT), Tuesday said that the Japanese Ministry of Health, Labour, and Welfare (MHLW) has approved Elevidys for the treatment of Duchenne muscular dystrophy under the conditional and time-limited approval pathway in Japan.
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.
The approval is based on the efficacy and safety data for Elevidys, which includes muscle health and longer-term functional results from the Elevidys clinical programs, including the two-year data from t...