Johnson & Johnson Seeks FDA Approval For Muscle Weakness Drug And Gears Up Showdown With Argenx and UCB

Thursday, Johnson & Johnson (NYSE:JNJ) announced the submission of a Biologics License Application (BLA) to the FDA seeking the first approval of nipocalimab globally for generalized myasthenia gravis (gMG).  gMG is an autoantibody-driven neuromuscular disease characterized by fluctuating muscle weakness. The update marks the first FDA submission for nipocalimab, an investigational treatment that binds with high affinity and specificity to block FcRn and reduce autoantibody levels. Also Read: Cartesian Therapeutics’ Rare Disease Candidate Shows Long Lasting Benefit Over Argenx’s Vyvgart, Analyst Initiates With Buy. The application included data from the ...