- Janssen, a unit of Johnson & Johnson JNJ, announced topline results from the proof-of-concept Phase 2 open-label UNITY trial for pregnant adults at high risk for severe hemolytic disease of the fetus and newborn.
- In 2020, Johnson & Johnson shelled out $6.5 billion to acquire Momenta Pharmaceuticals Inc, gaining access to its lead product, nipocalimab.
- HDFN is a rare condition that can cause life-threatening anemia in the fetus.
- It occurs when the blood types of a pregnant individual and their fetus are incompatible.
- Most of the 14 pregnant patients who received once-weekly intravenous infusions of nipocalimab achieved a live birth at or after 32 weeks of gestation without requiring an intrauterine transfusion throughout their pregnancy.
- During the treatment period of approximately 20 weeks, nipocalimab demonstrated a safety profile that supports further development of the treatment in HDFN.
- Over the roughly 20-week treatment period, nipocalimab’s safety profile supported further drug development in this fetal indication, J&J said.
- Katie Abouzahr, M.D., autoantibody portfolio development leader at Janssen Research & Development, said more data would be released at an upcoming scientific medical meeting while the company plans for a pivotal phase 3 study.
- Price Action: JNJ shares are down 0.86% at $163.20 on the last check Monday.
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