FDA Approves J&J's IMAAVY For Warm Autoimmune Hemolytic Anemia

(RTTNews) - Johnson & Johnson (JNJ) announced that the U.S. Food and Drug Administration (FDA) has approved IMAAVY (nipocalimab-aahu) for the treatment of warm autoimmune hemolytic anaemia (wAIHA) in adults and pediatric patients 12 years of age and older currently or previously treated with corticosteroids.

The approval, which follows FDA Priority Review, is based on the pivotal phase 2/3 ENERGY study, which demonstrated durable haemoglobin responses. IMAAVY has just become the first FDA-approved therapy specifically for warm autoimmune hemolytic anaemia (wAIHA).

Warm autoimmune hemolytic anaemia (wAIHA) is a rare, life-threatening condition where autoantibodies attach to and destroy red blood cells (RBCs), resulting in anaemia.

IMAAVY is an immunoselective treatment designed to target, bind with high affinity, and block the neonatal Fc receptor (FcRn), reducing circulating immunoglobulin G (IgG) antibodies that drive disease while also preserving B-cell function based on in vitro and/or in vivo studies.

ENERGY is a multicenter, randomised, double-blind, placebo-controlled Phase 2/3 study evaluating the efficacy and safety of nipocalimab compared with placebo, followed by an open-label extension period, in adults living with warm autoimmune hemolytic anaemia (wAIHA).

According to the company, the trial demonstrated that approximately three times as many patients receiving the approved dose of IMAAVY achieved durable Hgb levels as placebo by 24 weeks.

"As the first therapy approved for wAIHA, IMAAVY has the potential to redefine the management of wAIHA, particularly for those with uncontrolled disease." said David M. Lee, Global Immunology Therapeutic Area Head, Johnson & Johnson.

The current wAIHA treatment landscape includes corticosteroids, rituximab, and other off-label immunosuppressive and B-cell-directed therapies. Prior to IMAAVY, there were no FDA-approved treatments specifically indicated for wAIHA.

The current approval marks the second FDA nod for IMAAVY, as IMAAVY is already approved for the treatment of generalised myasthenia gravis (gMG) in adults and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive

JNJ has traded between $173.33 and $276.47 over the last year. The stock closed Monday's trade at $273.04, up 1.04%.

JNJ is currently down 0.52% in the overnight market.

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