Breaking News, Trials & Filings

J&J’s IMAAVY Approved by FDA for Treatment of Generalized Myasthenia Gravis

The approval is supported by data from the pivotal, ongoing Vivacity-MG3 study.

Author Image

By: Charlie Sternberg

Associate Editor

The U.S. Food and Drug Administration (FDA) has approved Johnson & Johnson’s IMAAVY (nipocalimab-aahu), a human FcRn-blocking monoclonal antibody, for the treatment of generalized myasthenia gravis (gMG). The approval, which follows FDA Priority Review designation, offers a new treatment option in a proven class with the potential for lasting disease control in the broadest population of people living with gMG (adults and pediatric patients 12 years of age and older who are anti-acetylcho...

Continue reading this story and get 24/7 access to Contract Pharma for FREE


Already a subscriber? Sign in

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters