Johnson & Johnson Reports the US FDA’s BLA Acceptance of Nipocalimab with Priority Review for Generalized Myasthenia Gravis (gMG)
Shots:
- The US FDA has accepted & granted priority review to the BLA of nipocalimab for treating patients with antibody positive (anti-AChR, anti-MuSK, anti-LRP4) gMG, based on P-III (Vivacity-MG3) trial. MAA in this indication has been filed with the EMA on Sep 11, 2024
- The P-III study assessed safety & efficacy of nipocalimab + SoC (30mg/kg, IV loading dose followed by 15mg/kg, Q2W) vs PBO for treating adults (n=199; 153 were antibody +ve) with antibody positive or negative gMG for 24wks.
- Trial depicted a significant reduction in MG-ADL scores (≥2-point improvement) vs with a sustained disease control after 24wks. in Ab +ve adults vs PBO
Ref: Johnson & Johnson | Image: Johnson & Johnson
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
