Otsuka Subsidiary Initiates US FDA Submission for Kidney Disease Drug
MT Newswires Live
Oct 07
Otsuka (TYO:4578) said its wholly owned unit, Otsuka Pharmaceutical Development & Commercialization, completed a rolling submission application to the US Food and Drug Administration for approval of its sibeprenlimab, Voyxact, on Tuesday.
The Japan-based drug maker said that the drug is used to reduce proteinuria in adults with IgA nephropathy at risk for disease progression, according to a Wednesday filing with the Tokyo bourse.
The company said that the drug secured accelerated approval last year.
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