Brazil is the first country to approve a drug for warm-antibody autoimmune hemolytic anemia

The medication is indicated for the treatment of a rare autoimmune disease

The Brazilian Health Regulatory Agency (Anvisa) has registered a new therapeutic indication for the drug Imaavy® (Nipocalimab). The medication is now approved for the treatment of warm-antibody autoimmune hemolytic anemia (WAIHA) in adults and patients aged 12 years or older. Brazil is the first country in the world to approve this indication for the drug.

WAIHA is a rare, serious, and potentially debilitating autoimmune disease associated with anemia, fatigue, shortness of breath, the need for blood transfusions, and the risk of other health complications. Its incidence is estimated at approximately 1 to 3 cases per 100,000 inhabitants per year.

Nipocalimab is a monoclonal antibody that blocks the neonatal Fc receptor (FcRn), reducing immunoglobulin G (IgG), recycling and circulating IgG levels, including the autoantibodies involved in red blood cell destruction in WAIHA.

Anvisa prioritized the analysis, since it targets a rare, serious, and debilitating disease for which there was no therapeutic alternative specifically approved in Brazil.

For more detailed information, you can check the full Resolution 3.289/2026