VOYXACT
Generic: SIBEPRENLIMAB
Basic Information
Manufacturer
Otsuka America Pharmaceutical, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
SUBCUTANEOUS
FDA Set ID
c8a93b32-0676-4704-86dc-cb65f425c6e5
Indications & 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 )
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 )
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Immunosuppression and Increased Risk of Infections [see Warnings and Precautions (5.1) ] Immunosuppression and Immunization Risks [see Warnings and Precautions (5.2) ] Most common adverse reactions are upper respiratory tract infection and injection site erythema.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc.
at 1-800-438-9927 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of VOYXACT was evaluated in a randomized, double-blind, placebo-controlled, clinical study in patients with IgAN (VISIONARY).
The median duration of exposure was 44 weeks in the 259 patients treated with VOYXACT and 48 weeks in the 251 patients administered placebo.
The most common adverse reactions (reported in ≥10% of patients treated with VOYXACT and at a higher incidence than placebo) in patients treated with VOYXACT and placebo, respectively, were infections (49% versus 45%) and injection site reactions (24% versus 23%).
The most common infection was upper respiratory infection (15% versus 14%), and the most common injection site reaction was injection site erythema (13% versus 12%).
Most adverse reactions were reported as mild or moderate in severity and resolved without treatment interruption or discontinuation.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc.
at 1-800-438-9927 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of VOYXACT was evaluated in a randomized, double-blind, placebo-controlled, clinical study in patients with IgAN (VISIONARY).
The median duration of exposure was 44 weeks in the 259 patients treated with VOYXACT and 48 weeks in the 251 patients administered placebo.
The most common adverse reactions (reported in ≥10% of patients treated with VOYXACT and at a higher incidence than placebo) in patients treated with VOYXACT and placebo, respectively, were infections (49% versus 45%) and injection site reactions (24% versus 23%).
The most common infection was upper respiratory infection (15% versus 14%), and the most common injection site reaction was injection site erythema (13% versus 12%).
Most adverse reactions were reported as mild or moderate in severity and resolved without treatment interruption or discontinuation.