Otsuka Holdings said its US subsidiary has finished the paperwork for the next step in VOYXACT's American life: full approval. Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) completed a rolling submission of a supplemental biologics license application (sBLA) to the US Food and Drug Administration on October 6, US time.
What is being sought
VOYXACT (sibeprenlimab) is already approved in the US on an accelerated basis for adults with IgA nephropathy, a kidney disease. The submission asks the FDA for Traditional Approval. A rolling submission lets a sponsor send sections of an application in stages, and Otsuka's announcement marks the point at which the last piece has gone in.
OPDC is the US subsidiary of Otsuka Pharmaceutical, which is wholly owned by Otsuka Holdings. The company's earlier two-year eGFR data were reported in August.
Guidance unchanged
Otsuka Holdings said its consolidated forecast for the year ending December 2026 is unchanged for now. It added that it regards VOYXACT as one of the products it expects to drive future growth, and called the filing important progress toward raising corporate value over the medium to long term.
The release gives no date for an FDA decision and does not say whether the agency has accepted the application. Completing a submission is a step in the process, not an approval.