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FDA Grants Fast Track Designation to Nipocalimab for Fetal Neonatal Alloimmune Thrombocytopenia

FDA Grants Fast Track Designation to Nipocalimab for Fetal Neonatal Alloimmune Thrombocytopenia

The FDA has granted fast track designation to nipocalimab (Johnson & Johnson) to reduce the risk of fetal neonatal alloimmune thrombocytopenia (FNAIT) in pregnant adults who are alloimmunized, according to a press release from the company. The drug is the only investigational therapy reported to be in clinical development for this indication. Nipocalimab is an FcRn blocker that works by blocking the transfer of immunoglobulin G alloantibodies from pregnant individuals to the infant through the placenta, according to the press release. Further, the drug does not suppress the broader immune systems of either the individual or the developing fetus.

Due to the phase 2 safety and efficacy results demonstrated in the UNITY (NCT03842189) trial, the company will proceed with phase 3 clinical trials focused on hemolytic disease of the fetus and newborn (HDFN). The UNITY trial was a phase 2 global, multicenter study that evaluated nipocalimab as a once weekly intravenous infusion for individuals with HDFN. The results showed that nipocalimab helped 54% of alloimmunized women achieve a safe life birth at or after 32 weeks’ gestation without the need for intrauterine transfusion throughout pregnancy.

The AZALEA (NCT05912517) trial is currently recruiting and will assess the efficacy of nipocalimab compared the placebo in decreasing fetal anemia with live neonates in individuals who are pregnant and at risk for severe HDFN, according to the clinical trial information. Individuals aged 18 to 45 years will be included with an estimated gestational age from week 13^0/7 to Week 16^6/7 at the time of treatment randomization. Individuals will also be included if they have a history of HDFN, have a presence of maternal alloantibody to RhD, Rhc, RhE, or RhC antigen with titers above the critical level, and are otherwise healthy based on physical examination, medical history, vital signs, 12-leadECG, and clinical laboratory tests.

In December 2023, nipocalimab was granted orphan drug designation for FNAIT by the FDA. Further, it was also granted breakthrough designation for the treatment of alloimmunized pregnant individuals who have a high risk of early-onset severe HDFN, according to an article in Pharmacy Times.

March 27, 2024

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