Janssen Reports P-II Trial (UNITY) Results of Nipocalimab for Pregnant Individuals at High Risk of Early-Onset Severe Hemolytic Disease of the Fetus and Newborn
Shots:
- The proof-of-concept P-II open-label trial evaluating nipocalimab in pregnant individuals at high risk for EOS HDFN, showed that 92% of pregnancies treated with nipocalimab resulted in a live birth, 54% achieved the 1EPs of a live birth at or after gestational age of 32wks. without IUTs vs 10% in the historic reference point, 1 infant required a simple (blood) transfusion
- All live-born infants (n=5/5) required a simple transfusion, 1 of the 12 live-born newborns needed exchange (blood) transfusion with no cases of fetal hydrops, and was well tolerated across all the dose groups
- If nipocalimab is approved, it would be 1st anti-neonatal Fc receptor treatment & 1st approved non-surgical intervention for pregnancies at high risk of HDFN in the US. The company plans for a P-III trial of nipocalimab for the same indication
Ref: PR Newswire | Image: Janssen
Related Posts:- Janssen Reports P-II Trial Results of Nipocalimab for the Treatment of Severe Hemolytic Disease
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