CENTER FOR DRUG EVALUATION AND RESEARCH

DIVISION of
DRUG INFORMATION

Your source for the latest drug information. Know the moment it happens.

​

FDA Approves Imaavy (nipocalimab-aahu) for Warm Autoimmune Hemolytic Anemia

The U.S. Food and Drug Administration has approved a new indication for Imaavy (nipocalimab-aahu) for the treatment of warm autoimmune hemolytic anemia (wAIHA) in adult and pediatric patients 12 years of age and older with inadequate response to corticosteroids or immunosuppressive therapy. Imaavy was previously approved for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

wAIHA is a condition in which the immune system mistakenly targets and destroys the body's own red blood cells, leading to anemia that can range from mild to severe and life-threatening. Like gMG, wAIHA is driven by harmful IgG autoantibodies.

Imaavy is a targeted therapy that works by blocking a protein in the body called the neonatal Fc receptor (FcRn), which normally keeps those disease-causing antibodies circulating in the blood. By blocking this receptor, Imaavy speeds up the removal of those harmful antibodies, helping to reduce the damage they cause.

Imaavy is administered as an intravenous infusion. The approval was granted to Janssen Biotech, Inc.

For more information visit:https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-drug-warm-autoimmune-hemolytic-anemia. 

This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO- FDA (1-888-463-6332) or 301-796-3400 from 8:00 am - 4:30 pm ET Monday - Friday. You can also email us at: druginfo@fda.hhs.gov.