JNJ submits application to EMA for nipocalimab for generalized myasthenia gravis
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Andrii Dodonov
- Johnson & Johnson (NYSE:JNJ) unit Janssen-Cilag has filed a Marketing Authorisation Application with the European Medicines Agency for nipocalimab for the treatment of generalized myasthenia gravis.
- The application is for the first indication of the monoclonal antibody.
- The filing is supported by data from the phase 3 Vivacity-MG3 study which showed that those who received nipocalimab plus standard of care had better outcomes than those who received placebo plus SOC. The primary endpoint of the study was improvement in the MG-ADL (Myasthenia Gravis – Activities of Daily Living) score from baseline through 24 weeks.
- J&J (JNJ) submitted a Biologics License Application to the U.S. FDA for nipocalimab for the same indication in late August.