08:47 AM EDT, 08/29/2024 (MT Newswires) -- Johnson & Johnson ( JNJ ) said Thursday it has submitted a Biologics License Application to the US Food and Drug Administration for the approval of nipocalimab to treat generalized myasthenia gravis, a chronic neuromuscular disease that causes weakness in the voluntary muscles.

The application was based on the company's phase 3 Vivacity-MG3 trial which demonstrated that results for participants who received nipocalimab plus standard of care were "superior" compared with placebo plus standard of care, Johnson & Johnson ( JNJ ) said.

Safety and tolerability of nipocalimab in the trial were "consistent" with other nipocalimab studies, the healthcare company said.

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