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J&J says top drug prospect works across autoimmune disorders

On Monday, Johnson & Johnson said one of its most closely watched experimental medicines appears to have positive effects on two autoimmune diseases, providing further support to a drug that, by the company’s estimates, could eventually generate billions of dollars in annual sales.

J&J didn’t release any data, but rather said the drug hit the main goals of a mid-stage clinical trial testing it in patients with Sjögren’s disease as well as a late-stage study focused on generalized myasthenia gravis, a rare condition known in short as gMG. The company plans to present more detailed results from both studies at upcoming medical meetings, and to engage with regulators about the path to approval in gMG.

Named nipocalimab, the drug has over the past year demonstrated what J&J calls “clinical efficacy” across four diseases caused by autoantibodies — a type of immune system foot soldier that attacks the body’s own proteins. Nipocalimab is among the most advanced in a new class of therapies that treat autoimmune disorders by blocking “FcRn,” a protein that keeps the most common antibody found in people from degrading.

In gMG, autoantibodies interrupt the communication between nerve cells and muscles, leading to muscle weakness in the eyes, face and limbs. J&J said that, in its study, patients on nipocalimab experienced a significant reduction in the severity of their symptoms over a roughly six-month period, compared to those who were given a placebo.

The same was true in the Sjögren’s study, which J&J said was the first ever to test an anti-FcRn therapy against this condition and have positive results. Sjögren’s is often characterized by dry eyes and mouth, though it can affect various organs like the kidneys and lungs as well as cause joint pain similar to arthritis. The National Institutes of Health estimate that between 1 million and 4 million people in the U.S. have the disease.

Together, the two trials could help build the case for a therapy J&J believes to be a possible blockbuster. In a December presentation, the company listed nipocalimab as one of seven experimental drug programs in its pipeline that have the potential to reach over $5 billion in yearly sales.

Previously, J&J disclosed high-level results from two additional trials of nipocalimab. One found the drug worked as intended in certain patients with hard-to-treat rheumatoid arthritis. The other enrolled pregnant adults at high risk for severe hemolytic disease of the fetus and newborn, or HDFN, a rare, serious blood disorder that can lead to life-threatening anemia in the fetus.

In that open-label study, J&J said nipocalimab met the main goal, as the majority of participants who received it had a live birth at or after 32 weeks of gestation, without the need for an infusion of red blood cells into the fetus during their pregnancy.

The Food and Drug Administration has not yet approved any therapies for HDFN or disease-modifying treatments for Sjögren’s. In gMG, meanwhile, it has cleared AstraZeneca’s Soliris and, in late 2021, Argenx’s Vyvgart — the first ever anti-FcRn medicine to get a nod from the agency. More recently, the FDA also greenlit AstraZeneca’s Ultomiris and UCB’s Zilbrysq and Rystiggo.

For J&J and its dealmakers, adding nipocalimab to that list would be validating, since the company spent $6.5 billion to acquire the drug’s former developer, Momenta Pharmaceuticals, in 2020.