Johnson & Johnson announced that its experimental drug, nipocalimab, has shown positive effects in treating two autoimmune diseases: Sjögren's disease and generalized myasthenia gravis (gMG). The drug achieved its main goals in both a mid-stage clinical trial for Sjögren's disease and a late-stage study for gMG, a rare condition that causes muscle weakness. Nipocalimab works by blocking FcRn, a protein that prevents the degradation of the most common antibody in humans, offering a new approach to treating autoimmune disorders.
In the gMG study, patients treated with nipocalimab experienced a significant reduction in symptom severity over approximately six months compared to those given a placebo. Similarly, the Sjögren's study, the first to test an anti-FcRn therapy for this condition, also reported positive results. Sjögren's disease, affecting between 1 million to 4 million people in the U.S., is characterized by symptoms such as dry eyes and mouth, and can impact various organs.
Nipocalimab has demonstrated clinical efficacy across four diseases caused by autoantibodies, making it one of the most advanced therapies in its class. Johnson & Johnson plans to present detailed results from these studies at upcoming medical meetings and engage with regulators regarding approval for gMG treatment. The company believes nipocalimab has the potential to become a blockbuster drug, with estimates suggesting it could generate over $5 billion in annual sales.
Previous trials have also shown nipocalimab's effectiveness in treating hard-to-treat rheumatoid arthritis and in preventing severe hemolytic disease of the fetus and newborn (HDFN) in high-risk pregnant adults. The FDA has yet to approve any therapies for HDFN or disease-modifying treatments for Sjögren's, but has approved other treatments for gMG, including AstraZeneca’s Soliris and Argenx’s Vyvgart, the first anti-FcRn medicine approved by the agency.
