Otsuka Pharmaceutical (OTCMKTS: OTSKY) announced that VOYXACT (sibeprenlimab‑szsi) received U.S. FDA Accelerated Approval for reducing proteinuria in adults with Primary Immunoglobulin A Nephropathy (IgAN) at risk for disease progression, becoming the first and only therapy to block A‑PRoliferation‑Inducing‑Ligand (APRIL) based on VISIONARY Phase III interim data showing a 51% placebo‑adjusted proteinuria reduction at nine months.
Regulatory Milestone
Item
Detail
Product
VOYXACT (sibeprenlimab‑szsi)
Company
Otsuka Pharmaceutical
Developer
Visterra, Inc. (wholly owned subsidiary)
Agency
U.S. Food and Drug Administration (FDA)
Approval Type
Accelerated Approval
Indication
Reduction of proteinuria in adults with primary IgAN at risk for progression
Study Basis
VISIONARY Phase III interim analysis (n=320)
Key Efficacy
51% placebo‑adjusted proteinuria reduction at 9 months (P<0.0001)
Mechanism
First‑in‑class APRIL blocker
Dosing
Subcutaneous injection once every 4 weeks
Clinical Evidence – VISIONARY Study
Endpoint
VOYXACT
Placebo
Result
Proteinuria reduction at 9 mo
50%
2%
51% placebo‑adjusted (P<0.0001)
Patient population
n=320
Significant treatment effect
Mechanism validation
APRIL blockade reduces Gd‑IgA1 production
Key pathogenic factor in IgAN
Drug Profile
Mechanism: Humanized monoclonal antibody that binds to and blocks APRIL, reducing production of pathogenic galactose‑deficient IgA1 (Gd‑IgA1)
Innovation:First‑in‑class APRIL blocker addressing an important initiating and sustaining factor in IgAN progression
Administration: Subcutaneous injection every 4 weeks offering patient convenience
Development: Designed and engineered by Visterra, Inc.; pre‑clinical and early‑stage trials conducted by Visterra
Market Impact & Outlook
Metric
Value
U.S. IgAN Prevalence
~130,000 diagnosed patients
At‑Risk Population
~40,000 patients with >1g/day proteinuria
Current Standard
ACEi/ARBs, SGLT2 inhibitors; no approved disease‑specific therapy
Pipeline Competition
Calliditas’ Tarpeyo (budesonide) approved; Travere’s sparsentan under review
Pricing
Expected $50,000‑70,000/year (aligns with rare disease biologics)
Peak Sales Forecast
$600‑900 million by 2030 (assuming 30% penetration of at‑risk patients)
Next Catalyst: Confirmatory VISIONARY data expected Q4 2026 for full approval
Forward‑Looking Statements This brief contains forward‑looking statements regarding VOYXACT’s commercial launch, market potential, and confirmatory trial outcomes. Actual results may differ materially due to risks including pricing negotiations, competitive dynamics, and regulatory conversion to full approval.-Fineline Info & Tech
By Fineline Cube 