Disease activity level improvement exceeds 70%, Johnson & Johnson's potential blockbuster monoclonal antibody receives breakthrough therapy designation.

Johnson & Johnson (JNJ.US) announced recently that the U.S. FDA has granted Breakthrough Therapy Designation (BTD) to its investigational antibody therapy nipocalimab targeting the neonatal Fc receptor (FcRn) for the treatment of moderate to severe Sjgrens disease (SjD) in adult patients. According to the press release, nipocalimab is the first therapy to receive BTD in the field of SjD. It is worth noting that this therapy was listed as one of the top 10 potential groundbreaking investigational therapies by the industry media Evaluate earlier this year. Nipocalimab is a potential "best-in-class" antibody therapy targeting FcRn. By binding to FcRn, it prevents pathogenic autoantibodies taken up by monocytes and endothelial cells from being re-released into the blood, instead they are degraded within the cell. Studies have shown that it can reduce IgG levels in the blood circulation, including pathogenic autoantibodies, by more than 75%. This antibody therapy holds promise for treating various autoimmune diseases mediated by autoantibodies. Previously, it had been granted Breakthrough Therapy Designation by the FDA for the treatment of pregnant women at high risk of severe hemolytic disease of the fetus and newborn (HDFN). Nipocalimab has also shown positive top-line results in the key Phase 3 clinical trial VIVACITY for the treatment of adult patients with generalized myasthenia gravis (gMG).