Japan-based NS Pharma filed for FDA approval Oct. 2 for its Duchenne muscular dystrophy treatment, dealing another blow to Sarepta, whose Duchenne drug was rejected by the FDA in August.
If approved, NS Pharma's viltolarsen would be the first drug to treat children born with Duchenne muscular dystrophy. Barring any problems, the drug could be approved by the agency by mid-2020 or sooner, though the agency has not yet set an approval decision date, according to STAT.
Sarepta aimed to release its drug, Vyondys 53, earlier this year, but it was rejected by the FDA in August due to safety concerns, including the risk of infections and kidney toxicity seen in animal experiments.
Sarepta has not yet announced a plan to address the FDA's concerns about its drug, but said it plans to meet with the FDA before the end of the year, according to STAT.
Sarepta's stock price has plummeted this year because of concern over its relationship with the FDA. Investors are also concerned manufacturing challenges have caused the drugmaker to delay development of its muscular dystrophy treatment.
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