Johnson & Johnson Reports Nipocalimab’s BLA Submission to the US FDA for Treating Generalized Myasthenia Gravi
Shots:
- Johnson & Johnson has submitted the BLA of nipocalimab (FcRn blocker) to the US FDA for treating generalized myasthenia gravis (gMG)
- The submission was based on P-III (Vivacity-MG3) trial assessing the sustained efficacy & safety of nipocalimab + SoC (30mg/kg, IV loading dose followed by 15mg/kg, Q2W) vs PBO + SoC in gMG adults (n=199; antibody +ve & -ve) with an insufficient response for 24wks.
- In the study, over 6mos. consistent dosing of nipocalimab + SoC showed sustained disease control as evaluated by MG-ADL improvement in antibody +ve adults (anti-AChR+, anti-MuSK+, anti-LRP4+)
Ref: Johnson & Johnson | Image: Johnson & Johnson
Related Posts:- Johnson & Johnson Reports the Results from 2 Trials of Nipocalimab to Treat Generalized Myasthenia Gravis (gMG) and Sjögren’s Disease (SjD)
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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.
