Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- 4 hours ago
- 1 min read
24/08/2026
Johnson & Johnson received FDA approval for nipocalimab for the treatment of warm autoimmune hemolytic anemia (Ref)
Johnson & Johnson announced that the US FDA approved IMAAVY® (nipocalimab-aahu; FcRn blocker) for adults and paediatric patients 12 years of age and older with warm autoimmune hemolytic anemia (wAIHA) who were currently or previously treated with corticosteroids.
The approval was based on the pivotal Phase 2/3, ENERGY study which demonstrated durable hemoglobin response, with approximately three times as many patients achieving a durable Hgb levels vs placebo.
The approval followed FDA priority review.
A mean increase in hemoglobin of 1 g/dL at Week 1 and a 3.5-point higher mean FACIT-Fatigue score vs placebo at Week 24 were observed in IMAAVY-treated patients.
The safety profile was consistent with the established safety profile of nipocalimab in generalized myasthenia gravis (gMG).
US FDA granted Orphan Drug Designation to gamgertamig for the treatment of pemphigus (Ref)
Lakefront Biotherapeutics announced that the US FDA granted Orphan drug designation to gamgertamig (BCMAxCD3 bispecific T cell engager) for the treatment of pemphigus.
Gamgertamig was being developed in collaboration with Gilead Sciences and was designed to target BCMA-expressing plasma cells and B-cell populations involved in autoantibody production.
