USFDA grants Fast Track designation to JnJ nipocalimab to reduce fetal neonatal alloimmune thrombocytopenia risk in alloimmunized pregnant adults

“Receiving Fast Track designation for nipocalimab in FNAIT underscores the urgency to address the unmet need for safe, effective, and targeted treatments to prevent FNAIT, a condition that could carry severe health consequences and even be fatal for the fetus or newborn,” said Katie Abouzahr, M.D., Vice President, Autoantibody and Maternal Fetal Immunology Disease Area Leader, Johnson & Johnson. “We are committed to applying our decades of immunology leadership to pioneer innovative approaches to transform treatment for patients and their families affected by FNAIT and other alloantibody-driven diseases of pregnancy.”

"Johnson & Johnson is conducting research and development for nipocalimab, an FcRn blocker, to address the significant unmet need in reducing the risk of FNAIT. Nipocalimab is believed to work by blocking the transfer of immunoglobulin G (IgG) alloantibodies from pregnant individuals to their babies through the placenta while not suppressing the broader immune systems of the pregnant individual or developing fetus. Johnson & Johnson is also proceeding with two Phase 3 trials focused on FNAIT. Nipocalimab was granted orphan drug designation by the U.S. FDA for FNAIT in December 2023," the release stated.

Nipocalimab is additionally being studied in hemolytic disease of the fetus and newborn (HDFN), another alloimmune disease of pregnancy with a similar disease mechanism, often referred to as the red blood cell counterpart to FNAIT. After Phase 2 safety and efficacy results from the UNITY trial, Johnson & Johnson is additionally proceeding with Phase 3 trials focused on HDFN.

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