JNJ Seeks First FDA Nod for Autoimmune Disease Drug Nipocalimab
J&J(JNJ) ZACKS·2024-08-31 01:11
Johnson & Johnson (JNJ) submitted abiologics license application (BLA) to the FDA seeking approval for nipocalimab, its investigational neonatal Fc receptor (FcRn) blocker, in generalized myasthenia gravis (gMG) indication.The FDA filing is supported by data from the phase III Vivacity-MG3 study, which evaluated nipocalimab in adults with gMG, including those with anti-AChR, anti-MuSK and anti-LRP4 positive antibodies. Data from the study showed that patients who received nipocalimab plus standard of care ( ...