A Prescription Drug User Fee Act target date of November 28, 2025 has been set for the application. The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License ...

PRINCETON, N.J., March 25, 2026--(BUSINESS WIRE)--Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) today announced new analyses from the Phase 3 VISIONARY trial evaluating VOYXACT® ...

Otsuka Pharmaceuticals recently announced that the FDA has accepted for review the biologics licence application (BLA) for sibeprenlimab. Sibeprenlimab acts as an a proliferation-inducing ligand ...

The trial met its primary endpoint showing a statistically significant reduction in 24-hour uPCR with sibeprenlimab vs placebo in patients with IgA nephropathy. Topline interim results were announced ...

Sibeprenlimab, a IgG2 monoclonal antibody that binds to a proliferation-inducing ligand, significantly reduces proteinuria compared with placebo in patients with high-risk IgA nephropathy, according ...

PRINCETON, N.J. & TOKYO--(BUSINESS WIRE)--Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka Pharmaceutical, Co. Ltd. (Otsuka) announce the decision to submit a Biologics ...

Otsuka Pharmaceutical has shared positive results from a late-stage study of its investigational monoclonal antibody sibeprenlimab in adults with the rare kidney disease immunoglobulin A nephropathy ...

In the Phase 3 VISIONARY study, sibeprenlimab achieved a statistically significant and clinically meaningful 51.2% (P<0.0001) reduction in proteinuria at nine months of treatment when compared to ...

The FDA granted accelerated approval to sibeprenlimab injection (Voyxact) for the reduction of proteinuria in adults with primary immunoglobulin A (IgA) nephropathy at risk for disease progression, ...

VOYXACT is the first and only FDA-approved treatment for adults with primary IgAN at risk for disease progression that selectively inhibits A PRoliferation Inducing Ligand (APRIL), a key immune driver ...

PRINCETON, N.J. & TOKYO, June 06, 2025--(BUSINESS WIRE)--Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical, Co. Ltd. (Otsuka) today presented results from a ...