J&J seeks first approval of nipocalimab for gMG
US healthcare giant Johnson & Johnson (NYSE: JNJ) said yesterday that it has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) seeking the first approval of nipocalimab globally for the treatment of people living with generalized myasthenia gravis (gMG).
The company acquired nipocalimab through its $6.5 billion takeover of Momenta Pharmaceuticals back in 2020, and J&J has indicted that the candidate can generate peak sales in excess of $5 billion.
The application included data from the Phase III Vivacity-MG3 study which showed that outcomes for a broad population of antibody positive participants who received nipocalimab plus standard of care (SOC) were superior compared to those who received placebo plus SOC.
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