06:17 AM EST, 01/23/2025 (MT Newswires) -- Johnson & Johnson ( JNJ ) said Thursday its phase 3 study of experimental therapy, nipocalimab, in adults with generalized myasthenia gravis met its primary endpoint.

The company said the study showed a statistically significant and clinically meaningful improvement in the MG-ADLa score, which measures the impact of myasthenia gravis on daily activities, over 24 weeks.

Nipocalimab was well tolerated, with adverse events leading to discontinuation at rates similar to placebo.

The drugmaker said it submitted a biologics license application to the US Food and Drug Administration and a marketing authorization application to the European Medicines Agency for nipocalimab on Aug. 29 and Sept. 11, 2024, respectively.