J&J: applies to FDA for nipocalimab
(CercleFinance.com) - Johnson & Johnson has submitted an application to the FDA for the first worldwide approval of nipocalimab to treat generalized myasthenia gravis (gMG).
The application is based on data from a Phase III study which showed that nipocalimab, added to standard care, 'significantly' improved patient outcomes compared to placebo.
The company reports that nipocalimab is the first FcRn blocker to demonstrate sustained disease control over six months.
Johnson & Johnson hopes that this treatment will offer an innovative solution for people living with autoimmune diseases such as gMG.
Copyright (c) 2024 CercleFinance.com. All rights reserved.
The application is based on data from a Phase III study which showed that nipocalimab, added to standard care, 'significantly' improved patient outcomes compared to placebo.
The company reports that nipocalimab is the first FcRn blocker to demonstrate sustained disease control over six months.
Johnson & Johnson hopes that this treatment will offer an innovative solution for people living with autoimmune diseases such as gMG.
Copyright (c) 2024 CercleFinance.com. All rights reserved.