Johnson & Johnson (JNJ.US) submits application for potential blockbuster therapy

Johnson & Johnson (JNJ.US) announced that it has submitted a Biologics License Application (BLA) to the US FDA seeking global first approval of its investigational FcRn-targeting antibody therapy, nipocalimab, for the treatment of generalized myasthenia gravis (gMG). According to a previous press release, the therapy was the first FcRn inhibitor to demonstrate superiority over placebo in improving patient daily living activities (MG-ADL) scores when used in combination with standard of care (SOC) in antibody-positive gMG patients, including anti-AChR+, anti-MuSK+, and anti-LRP4+ patients. Given nipocalimab's potential to treat various autoimmune diseases, the therapy was ranked as one of the top 10 potential blockbuster pipeline therapies by industry media Evaluate earlier this year.