Biologics

J&J Files sBLA for Imaavy in Rare Anemia

Johnson & Johnson has submitted a supplemental BLA seeking approval of Imaavy as a treatment for warm autoimmune hemolytic anemia (wAIHA), a rare and potentially life-threatening blood disorder that currently has no FDA-approved therapies. The drug was approved by FDA 4/2025 for generalized myasthenia gravis in patients aged 12 and older who are acetylcholine receptor or muscle-specific kinase antibody positive.

If approved, nipocalimab would become the first treatment specifically for wAIHA, an autoimmune disease in which immunoglobulin G (IgG) autoantibodies bind to and destroy red blood cells, leading to hemolytic anemia. Patients with wAIHA face a 20% to 30% higher risk of death compared with the general population, according to the company.

The regulatory filing is supported by data from the pivotal Phase 2/3 ENERGY trial, a multicenter, randomized, double-blind, placebo-controlled study evaluating nipocalimab in adults with wAIHA. In the trial, a significantly greater proportion of patients treated with nipocalimab achieved the primary endpoint of a durable hemoglobin response compared with placebo. The study defined a durable response as reaching a hemoglobin level above 10 g/dL with an increase of at least 2 g/dL from baseline, sustained for at least 28 days without the need for rescue therapy.

Beyond improvements in hemoglobin, patients receiving Imaavy also experienced rapid and sustained reductions in fatigue, as measured by the FACIT-Fatigue scale, a patient-reported outcome considered clinically meaningful in wAIHA, it says

Nipocalimab is designed to selectively inhibit the neonatal Fc receptor (FcRn), which plays a central role in recycling IgG antibodies, according to the company. By blocking FcRn, the drug lowers circulating IgG levels, including pathogenic autoantibodies, while preserving other aspects of immune function, such as certain B-cell responses to new infections.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome