The FDA has approved Imaavy™ (nipocalimab-aahu) for the treatment of generalized myasthenia gravis in patients aged 12 years and older who are AChR or anti-muscle-specific tyrosine kinase antibody ...

The FDA approved nipocalimab in part on the basis of the phase III Vivacity-MG3 trial in 196 adults with gMG. The primary endpoint was the difference between nipocalimab and placebo in the 24 ...

The approval is based on results from an ongoing VivaCity MG3 study, which showed that the drug combined with standard of care improved disease control over 24 weeks significantly compared to a ...

The FDA’s decision on the drug was based on results from the phase 3 Vivacity-MG3 study, in which adult gMG patients receiving Imaavy plus standard of care achieved superior disease control throughout ...

The safety profile of J&J’s antibody was consistent across the Vivacity-MG3 and the ongoing Vibrance-MG trials. Credit: Manuel Esteban/Shutterstock. Johnson & Johnson’s (J&J) human neonatal Fc ...

This approval is based on data from the pivotal Vivacity-MG3 study and its ongoing open-label extension, which demonstrated that IMAAVY, an FcRn-blocking monoclonal antibody, provided long-lasting ...

This approval is based on data from the pivotal Vivacity-MG3 study and its ongoing open-label extension, which demonstrated that IMAAVY, an FcRn-blocking monoclonal antibody, provided long-lasting ...

1 The approval of the FcRn-blocking monoclonal antibody, which works by reducing immunoglobulin G (IgG), was supported by data from the ongoing Vivacity-MG3 study. Nipocalimab joins a roster of ...

Today’s approval, as well as the FDA Priority Review designation announced in January, were based in part on results from the phase 3 Vivacity-MG3 trial. That study showed that patients who ...

The FDA's decision was based on the phase III Vivacity-MG3 study and its ongoing open-label extension. The primary endpoint in Vivacity-MG3 was the change in Myasthenia Gravis Activities of Daily ...

The approval is supported by data from the pivotal, ongoing Vivacity-MG3 study – the longest primary endpoint of a registrational trial of any FcRn blocker in adults with living with gMG. Highlights ...

The approval was supported by data from the randomized, double-blind, placebo-controlled phase 3 Vivacity-MG3 study (ClinicalTrials.gov Identifier: NCT04951622), which enrolled adults with gMG ...