OTSUKA PHARMACEUTICAL DEVELOPMENT & COMMERCIALIZATION, INC.

Otsuka Submits BLA for Sibeprenlimab: A Novel Targeted Therapy for IgA Nephropathy

2 months ago

• Otsuka has filed a Biologics License Application with the FDA for sibeprenlimab, a monoclonal antibody that selectively inhibits APRIL, a key cytokine in IgA nephropathy pathogenesis. • The submission is supported by successful Phase 2 ENVISION and Phase 3 VISIONARY clinical trials, which demonstrated significant reduction in proteinuria compared to placebo after nine months of treatment. • If approved, sibeprenlimab would offer patients a convenient subcutaneous injection administered every four weeks, with the option for self-administration at home, addressing a significant unmet need in IgA nephropathy treatment.

FDA to Review Rexulti for PTSD Treatment Amidst PDUFA Delay

5 months ago

• The FDA will convene a Psychopharmacologic Drugs Advisory Committee (PDAC) to review Rexulti (brexpiprazole) in combination with sertraline for treating PTSD in adults. • The FDA's decision to host a PDAC meeting indicates a delay in the Prescription Drug User Fee Act (PDUFA) target action date, originally set for February 8, 2025. • Clinical trial data supports the combination of brexpiprazole and sertraline, showing statistically significant improvements in PTSD symptoms compared to sertraline alone. • Rexulti, developed by Otsuka and Lundbeck, is already approved for major depressive disorder, schizophrenia, and agitation associated with Alzheimer's disease.

Otsuka's Sibeprenlimab Shows Positive Phase 3 Interim Results for IgA Nephropathy

7 months ago

• Otsuka Pharmaceutical's sibeprenlimab demonstrated a statistically significant and clinically meaningful reduction in 24-hour urine protein-to-creatinine ratio (uPCR) compared to placebo. • The Phase 3 VISIONARY trial met its primary endpoint after nine months of treatment in adults with IgA nephropathy. • Otsuka plans to discuss the interim results with the FDA, potentially leading to an accelerated regulatory submission for sibeprenlimab. • Sibeprenlimab targets APRIL, a key factor in the immune pathogenic cascade of IgA nephropathy, offering a potential new therapeutic strategy.