J&J submits FDA application for myasthenia gravis drug nipocalimab
by Contributor since / Followers
4 months ago
Johnson & Johnson (NYSE:JNJ) said that it has submitted a Biologics License Application (BLA) to the FDA for its drug candidate nipocalimab for the treatment of generalized myasthenia gravis, or gMG.
The pharmaceutical giant said it was the first global submission for the therapy, according to a statement.
Argenx (ARGX), UCB and AstraZeneca (AZN) already have drugs on the market to treat MG, a rare autoimmune disease that causes profound muscle weakness and extreme fatigue.
Other companies working on treatments for the condition include Roche (OTCQX:RHHBY), Alnylam (ALNY), Regeneron (REGN), Dianthus Therapeutics (DNTH), Cartesian Therapeutics (RNAC), Amgen (AMGN) and Immunovant (IMVT).