J&J: FDA priority review for MGg

(CercleFinance.com) - Johnson & Johnson (NYSE: JNJ) announced that the Biologics License Application (BLA) for nipocalimab has received Priority Review designation from the US FDA.


This product is used for the treatment of antibody-positive (anti-AChR, anti-MuSK, anti-LRP4) patients with generalized myasthenia gravis (gMG), as supported by the results of the Vivacity-MG3 phase 3 study.

MGg is a rare, lifelong, chronic disease caused by autoantibodies, for which no cure is currently available. MGg affects around 700,000 people worldwide.

The FDA grants priority review to drug applications which, if approved, would offer significant improvements in safety or efficacy in the treatment, diagnosis or prevention of serious diseases over standard applications.

We welcome the FDA's decision to grant priority review for the treatment of generalized myasthenia gravis, which underscores the need for additional treatment options in a large population of people living with MGg, Johnson & Johnson said.

We are committed to working closely with the FDA to help bring nipocalimab as a potential treatment to certain MGg patients. If approved, nipocalimab has the potential to treat gMG in individuals positive for antibodies, including anti-AChR, anti-MuSK and/or anti-LRP4.


Copyright (c) 2025 CercleFinance.com. All rights reserved.