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
Related News:- Johnson & Johnson Reports the EC’s Approval of Rybrevant (Amivantamab) Plus Lazcluze (Lazertinib) as a 1L Treatment of EGFRm NSCLC
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