- FDA granted Priority Review to Janssen’s sBLA for IMAAVY (nipocalimab), shortening the FDA review to ~6 months.
- Pivotal Phase 2/3 ENERGY (NCT04119050) showed more nipocalimab-treated patients achieved a durable hemoglobin response (≥10 g/dL and ≥2 g/dL rise for ≥28 days) and improved FACIT‑Fatigue versus placebo.
- IMAAVY is an FcRn blocker that reduces circulating IgG autoantibodies and is being studied across multiple auto‑ and alloantibody‑driven indications (gMG approval and trials in HDFN, FNAIT, SjD, SLE).
FDA Priority Review
The FDA has granted Priority Review to Janssen’s supplemental BLA for IMAAVY (nipocalimab‑aahu) for warm autoimmune hemolytic anemia (wAIHA), shortening the review to about six months; IMAAVY is the first therapy to receive Priority Review for wAIHA.
ENERGY trial findings
Pivotal Phase 2/3 ENERGY (NCT04119050) showed more nipocalimab‑treated patients achieved a durable hemoglobin response—hemoglobin ≥10 g/dL and ≥2 g/dL increase from baseline for ≥28 days—versus placebo, alongside improvements in fatigue measured by FACIT‑Fatigue; full ENERGY results will be presented at an upcoming medical conference.
Mechanism and clinical program
IMAAVY is an FcRn blocker designed to reduce circulating IgG, including pathogenic autoantibodies, while preserving key immune functions; nipocalimab is being investigated across auto‑ and alloantibody‑driven indications, including generalized myasthenia gravis (approved for adults and patients ≥12 who are AChR‑ or MuSK‑antibody positive) and conditions such as HDFN, FNAIT, Sjögren’s disease and SLE.
Regulatory status and safety
Nipocalimab has received multiple regulatory designations (including FDA Fast Track and Orphan Drug statuses for selected indications); IMAAVY’s safety profile includes increased risk of infections, hypersensitivity/infusion reactions and peripheral edema as noted in the prescribing information.
