Both the P-II (DAHLIAS) & P-III (VIVACITY) trials evaluated the safety & efficacy of Nipocalimab vs PBO in patients with gMG & SjD. The company expects to present the data from the trials at upcoming medical conferences
In the P-III trial the study met its 1EP by achieving a statistically significant reduction in MG-ADL score from baseline from wk22-wk24 vs PBO whereas the P-II trial also met its 1EP by depicting a statistically significant reduction in clinESSDAI score from baseline at wk.24 vs PBO
Nipocalimab is mAB that selectively blocks FcRn to reduce levels of circulating IgG Ab. Earlier in Dec 2021 Nipocalimab received the US FDA’s ODD for gMG along with other designations for other indications
Ref: Johnson & Johnson | Image: Johnson & Johnson
Related Posts:- 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
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