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Innovative Medicine
May 12, 2026
Johnson & Johnson showcases hematology leadership with 30+ presentations at the 2026 European Hematology Association (EHA) Congress
· Johnson & Johnson will present 30+ abstracts at European Hematology Association 2026, highlighting leadership in hematology with data across multiple myeloma and leukemia, and first pivotal data in warm autoimmune hemolytic anemia · Phase 3 results evaluate the potentially transformative investigational combination of TALVEY®, the first GPRC5D‑targeted bispecific antibody, in combination with DARZALEX FASPRO® with or without pomalidomide for patients with relapsed or refractory multiple myeloma in earlier lines of therapy · Pivotal Phase 2/3 results potentially position IMAAVY® as the first FDA-approved treatment for warm autoimmune hemolytic anemiaa designed to target the IgG autoantibodies responsible for red blood cell destruction
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Innovative Medicine
April 27, 2026
FDA grants Priority Review for IMAAVY® (nipocalimab-aahu) as the potential first approved treatment for people living with warm autoimmune hemolytic anemia (wAIHA)
Priority Review is granted to medicines that may offer significant improvements in safety or effectiveness for serious conditions like warm autoimmune hemolytic anemia, a life-threatening disease in which pathogenic immunoglobulin G autoantibodies attach to and destroy red blood cells, leading to debilitating anemia IMAAVY is designed to target the underlying cause of warm autoimmune hemolytic anemia by reducing circulating immunoglobulin G, including autoantibodies, while preserving critical immune functions Pivotal study showed rapid and durable hemoglobin responsea and fatigue improvementb compared to placebo in patients with warm autoimmune hemolytic anemia
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Innovative Medicine
April 22, 2026
IMAAVY® (nipocalimab-aahu) shows over two years of sustained disease control in a broad population with generalized myasthenia gravis (gMG)
Through 120 weeks of follow-up, IMAAVY delivered sustained clinical improvements and reductions in total IgG in antibody-positive adult patients including anti-AChR+ and anti-MuSK+ Patients achieving sustained minimal symptom expression (MSE) experienced greater improvements in quality of life than those with transient MSE in a post-hoc analysis of the Phase 3 study EPIC, the first head-to-head study of IMAAVY versus another FcRn blocker in generalized myasthenia gravis, is now enrolling participants
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Innovative Medicine
March 3, 2026
Johnson & Johnson therapy nipocalimab granted U.S. FDA Fast Track designation in systemic lupus erythematosus (SLE)
Fast Track designation reflects the unmet need in this serious disease and enables the potential for an accelerated FDA review timeline The designation is supported by a Phase 2 study in which nipocalimab demonstrated reduction in lupus disease activity and potential for steroid sparing Systemic lupus erythematosus is a debilitating, chronic autoantibody-driven disease affecting multiple organs, with limited treatment options and risk of irreversible organ damage Johnson & Johnson is actively enrolling patients in a Phase 3 study of adults with active systemic lupus erythematosus
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Innovative Medicine
February 24, 2026
Johnson & Johnson seeks FDA approval of IMAAVY® (nipocalimab-aahu) as the first-ever FDA-approved treatment for warm autoimmune hemolytic anemia (wAIHA)
Data from the pivotal ENERGY trial showed IMAAVY® produced a rapid and durable hemoglobin responsea in wAIHA Currently no FDA-approved therapies are available for wAIHA, a rare, heterogeneous, life-threatening disease in which pathogenic immunoglobulin (IgG) autoantibodies attach to and destroy red blood cells, leading to debilitating anemia
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Innovative Medicine
January 6, 2026
Johnson & Johnson unveils new data showing nipocalimab is the first and only investigational FcRn blocker with potential to reduce systemic lupus erythematosus (SLE) activity in a Phase 2 study
The JASMINE study met the primary endpoint and key secondary and exploratory endpoints, including those indicating the potential of nipocalimab for steroid sparing SLE is one of the most prevalent and debilitating autoantibody diseases, causing one’s own immune system to mistakenly attack various tissues, which can lead to potentially life-threatening systemic organ damage Based on these positive topline results, the company plans to initiate a Phase 3 program for nipocalimab in SLE
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