By Johnson & Johnson has reported positive results for its drug nipocalimab in a Phase 2 clinical trial. The drug has been shown to treat pregnant patients at risk for early-onset severe hemolytic disease of the fetus and newborn, a rare blood disorder which can be fatal.
According to the results, 92% of pregnant people treated with nipocalimab had a live birth. The drug also significantly increased the proportion of pregnancies that resulted in a live birth at or after 32 weeks without intrauterine transfusions.
As a result of the success of the Phase 2 trial, Johnson & Johnson’s subsidiary, the Janssen Pharmaceutical Cos., is planning a Phase 3 clinical trial for nipocalimab.
Nipocalimab was previously given fast-track designation in 2019 and orphan drug status in 2020 by the Food and Drug Administration (FDA). This status is reserved for potential treatments of rare medical conditions.
This news marks an important step forward in the treatment of pregnant patients at risk for early-onset severe hemolytic disease of the fetus and newborn, and Johnson & Johnson will continue to pursue the development of this potentially life-saving drug.
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