sibeprenlimab
Drug Details
- Generic Name
- sibeprenlimab
- Brand Names
- VOYXACT
- Application Number
- BLA761434
- Sponsor
- Otsuka America Pharmaceutical, Inc.
- NDC Codes
- 1
- Dosage Forms
- INJECTION
- Routes
- SUBCUTANEOUS
- Active Ingredients
- SIBEPRENLIMAB
Indications and Usage
1 INDICATIONS AND USAGE VOYXACT is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether VOYXACT slows kidney function decline over the long-term in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial. VOYXACT is an A Proliferation Inducing Ligand (APRIL) blocker, indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. ( 1 ) This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether VOYXACT slows kidney function decline over the long-term in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial. ( 1 )