Johnson & Johnson is asking the Food and Drug Administration to approve a new medicine the company believes can eventually be used to treat many diseases.
The initial submission covers use of the drug, called nipocalimab, in patients with generalized myasthenia gravis, J&J said Thursday. The condition causes a patient’s immune system to attack proteins that are needed for muscles to keep functioning properly. Symptoms can range from limb weakness to difficulty chewing, swallowing and breathing.
Nipocalimab belongs to a class of drugs known as FcRn blockers, which work by reducing the circulation of antibodies that interfere with key bodily functions. In the case of generalized myasthenia gravis, J&J’s drug is designed to lessen the interference between nerves and muscles while still preserving immune function.
In a Phase 3 study, J&J found that nipocalimab could help patients better control the disease when added to standard treatments over the course of six months. The company says that’s the longest dataset available for a FcRn blocker in patients with the condition.
If approved, nipocalimab will enter a competitive market for treatments for generalized myasthenia gravis, which has drawn greater interest from drugmakers in recent years. Argenx in 2021 won approval to sell the first FcRn blocker for the condition, while UCB recently followed with Rystiggo. Alexion’s Ultomiris and Soliris are also used to treat the condition. Another potential option, from Roche, recently disappointed in a clinical trial.
J&J has high hopes for nipocalimab, which it says has the “potential to define the standard of care across autoantibody-driven diseases.” In addition to rare diseases, the company is studying the drug’s use in common conditions such as rheumatoid arthritis. J&J says the medicine could eventually be approved for 10 different disease indications.
Generalized myasthenia gravis affects about 100,000 people in the U.S. and an estimated 700,000 worldwide.