← All upcoming FDA decisions

Imaavy (nipocalimab-aahu) for Warm autoimmune hemolytic anemia

Johnson & Johnson (Janssen) · sBLA
Approved
The FDA approved this application. Approval is the starting line, not the finish: our guide to what happens in the 90 days after a rare disease approval walks through specialty pharmacies, insurance review, and how families shorten the wait.

What the FDA decided

The FDA approved Johnson & Johnson (Janssen)'s sBLA for Imaavy (nipocalimab-aahu) in Warm autoimmune hemolytic anemia. The first FDA-approved treatment for warm autoimmune hemolytic anemia, for patients 12 and older who are taking or have taken corticosteroids. Imaavy was already approved in 2025 for generalized myasthenia gravis. In the 24-week, 118-patient placebo-controlled trial (NCT04119050), 24% of patients on the 30 mg/kg every-4-weeks dose had a durable hemoglobin response versus 8% on placebo; the 15 mg/kg every-2-weeks dose did not beat placebo.

About the drug

Imaavy: anti-FcRn monoclonal antibody that reduces pathogenic IgG autoantibodies by blocking the neonatal Fc receptor. Our full Imaavy profile covers how it works, side effects in plain language, and its trial history.

Our coverage

Rystiggo for Myasthenia Gravis and How It Compares to Vyvgart and Imaavy
Rystiggo (rozanolixizumab-noli) is an FcRn inhibitor approved for adults with anti-AChR or anti-MuSK antibody-positive generalized myasthenia gravis. This guide…

Frequently asked questions

When will the FDA decide on Imaavy?

The FDA has already decided: the application was approved. See the outcome details above.

What is Imaavy being reviewed for?

Johnson & Johnson (Janssen) submitted a sBLA for Imaavy in Warm autoimmune hemolytic anemia. The first FDA-approved treatment for warm autoimmune hemolytic anemia, for patients 12 and older who are taking or have taken corticosteroids. Imaavy was already approved in 2025 for generalized myasthenia gravis. In the 24-week, 118-patient placebo-controlled trial (NCT04119050), 24% of patients on the 30 mg/kg every-4-weeks dose had a durable hemoglobin response versus 8% on placebo; the 15 mg/kg every-2-weeks dose did not beat placebo.

What happens after the Imaavy decision?

If approved, availability is not immediate: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. If the FDA issues a complete response letter, the application was not approved in its current form; CRLs are often about manufacturing or data presentation rather than efficacy, and sponsors frequently resubmit. This page updates with the outcome either way.

Where this date comes from

The FDA does not publish PDUFA dates; companies disclose them. This one comes from FDA approval notice. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified daily.