Fetal and neonatal alloimmune thrombocytopenia (FNAIT) is an exceedingly rare disorder in which a pregnant woman passes on antibodies that attack fetal platelets, which are blood cells necessary for clot formation to stop bleeding. This raises the risk of internal bleeding, including intracranial hemorrhage, and may result in fetal death.
FNAIT is typically treated with intravenous immunoglobulin infusion, which may be administered during pregnancy or immediately after birth. In addition, platelet transfusions may be administered to increase platelet cell count.
The goal of treatment is to prevent bleeding during pregnancy or just after birth. One of the biggest hindrances to care remains undiagnosed FNAIT. This disorder is typically discovered only incidentally when there is a reason for clinical suspicions to be raised, such as when bleeding complications occur in a baby from a previous pregnancy.
Read more about FNAIT testing and diagnosis
About nipocalimab
Nipocalimab, developed by Johnson & Johnson, received US Food and Drug Administration (FDA) Fast Track designation in 2024.
The Fast Track designation is intended to expedite the development of therapies that show promise in treating severe or life-threatening conditions. The Fast Track designation was granted because nipocalimab showed promising efficacy and safety in phase 2 studies. It works by blocking the transfer of immunoglobulin G alloantibodies from the pregnant woman to the fetus while preserving their respective immune systems.
Johnson & Johnson is proceeding with phase 3 studies to further establish the facts surrounding the safety and efficacy of nipocalimab in treating FNAIT. Nipocalimab is also being investigated in treating a similar disorder known as hemolytic disease of the fetus and newborn (HDFN).
The future of the FNAIT therapeutic space
It is important to recognize that nipocalimab may positively affect FNAIT care once further studies have been conducted.
In a news release, the company released a statement that reads: “When completed, this research will further define the unmet needs in these rare conditions caused by placental transfer of alloantibodies which pose significant risk to the fetus or newborn.”
It’s important to note that nipocalimab is not the only therapy in development for FNAIT. RLYB212, developed by Rallybio, is a recombinant human monoclonal anti-HPA-1a IgG antibody that selectively binds to the HPA-1a isoform of integrin β3. Additionally, immunoprophylaxis and intravenous immunoglobulin (IVIG) are often used to treat the condition.
One of the ways that public health authorities are seeking to diagnose FNAIT and treat it early is via campaigns that increase awareness about this condition. When this diagnosis is picked up, it makes it easier for clinicians to use existing therapies to optimize outcomes. With a renewed focus on early diagnosis and care, any future therapies will be able to complement current efforts to improve outcomes in patients who have been diagnosed with FNAIT.
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