Janssen Reports P-II Trial Results of Nipocalimab for the Treatment of Severe Hemolytic Disease
Shots:
- The company reported the results from the PoC P-II open-label (UNITY) trial evaluating nipocalimab (IV, qw) in 14 patients who are at high risk for sev. HDFN
- The trial met its 1EPs i.e., the results showed that patients treated with nipocalimab achieved a live birth at or after the gestational age of 32wks. without the need for an intrauterine transfusion throughout their entire pregnancy. The therapy also showed a safety profile thus supporting further development for HDFN
- Nipocalimab received FTD in July 2019 & ODD in June 2020 from the US FDA while orphan medicinal product designation from the EMA in Oct 2019 for HDFN. Based on the P-II trial, the company plans for the P-III trial
Ref: PrnewsWire | Image: Janssen
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