The importance of nipocalimab’s FTD against FNAIT


Learn from Paige Meizlik, MD, MSTR, about the FDA's Fast Track Designation for nipocalimab, offering hope for addressing the critical unmet needs in treating fetal neonatal alloimmune thrombocytopenia and advancing maternal-fetal immunology research.

In a recent interview, Paige Meizlik, MD, MSTR, director of clinical research for maternal fetal immunology at Johnson & Johnson, discussed the significance of the Fast Track Designation (FTD) granted to nipocalimab (M281; Johnson & Johnson) for treating fetal neonatal alloimmune thrombocytopenia (FNAIT) by the FDA.

There is currently an unmet need among patients with FNAIT, with significant impact seen among pregnant patients and their families. Diagnoses and treatment are challenging, as many cases are not properly diagnosed, and no treatment has received approval in the United States.

Care for FNAIT is often time consuming and may include invasive procedures. Nipocalimab promises an easier solution as an FcRn blocker designed to block maternal-fetal immunoglobulin G transfer. This can improve platelet count at birth, reducing the risks of bleeding, hemorrhage, and death.

Nipocalimab has also been evaluated for treating hemolytic disease of the fetus and newborn (HDFN). It has displayed positive phase 2 data against this condition, indicating the endpoint of livebirth at 32 weeks among patients with severe early-onset HDFN was successfully met.

A phase 3 trial has begun to evaluate the efficacy of nipocalimab against FNAIT, which is considered a sister disease to HDFN, where maternal alloantibodies attack fetal red blood cells during pregnancy.

The FTD will lead to the development timeline of nipocalimab being expedited. It is granted to severe, life-threatening diseases and allows manufacturers to closely communicate with the FDA to provide new therapeutic options sooner.

Meizlik stated that receiving the FTD has underscored the urgency for addressing safe and effective treatment for FNAIT. As a condition that may be fetal for the fetus and affect pregnant women, it impacts 2 patients instead of just 1.

To conclude, Meizlik expressed the research team’s excitement to contribute to knowledge about FNAIT and how to treat patients impacted by the condition. The FTD is only the start of development of nipocalimab against FNAIT.

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