Sarepta Therapeutics (SRPT) said Tuesday that Elevidys has received approval for the treatment of Duchenne muscular dystrophy under Japan's conditional and time-limited approval pathway, which provides for marketing authorization in the country for up to seven years.

The Japanese Ministry of Health, Labor and Welfare approved Elevidys for patients aged three to less than eight years old, who don't have any deletions in exon 8 and/or exon 9 in the DMD gene and are negative for anti-AAVrh74 antibodies, Sarepta said.

The company said the approval is based on data that treatment with Elevidys resulted in "significantly better outcomes" in various motor function measures compared with a well-matched external control group.

Sarepta said it is responsible for regulatory approval and commercialization of Elevidys in the US, as well as manufacturing, while its collaboration partner Roche is responsible for regulatory approvals and bringing the treatment to the rest of the world.

Sarepta said it is eligible to receive near-term regulatory and commercial milestone payments of up to $103.5 million.

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