Johnson & Johnson Reports the US FDA’s Approval of Imaavy (Nipocalimab-aahu) for Generalized Myasthenia Gravis (gMG)
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- The US FDA has approved Imaavy to treat antibody +ve gMG pts (≥12yrs.) under priority review based on the ongoing P-III (Vivacity-MG3) trial assessing Imaavy + SoC vs PBO + SoC in antibody +ve or -ve adults (N=199; 153 were Ab +ve); global regulatory review is ongoing
- Trial showed superior disease control per MG-ADL score & a rapid, sustained reduction in autoantibody levels by up to 75% from the 1st dose over 24wks; responses were sustained till 20mos. of follow-up in the ongoing OLE study
- The P-II/III (Vibrance-MG) pediatric trial met its 1EP, with Imaavy (IV, Q2W) + SoC showing a 69% total serum IgG reduction over 24wks. along with 2EPs of improved MG-ADL & QMG scores
Ref: Johnson & Johnson | Image: Johnson & Johnson
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Ridhi is an avid secondary researcher who follows trends in the biopharmaceutical and healthcare sectors to curate engaging content for the global audience. She works as a news editor at PharmaShots and loves to read books and explore new destinations.
