Monday, Johnson & Johnson (NYSE: JNJ) announced topline results from the pivotal Phase 3 VIVACITY study of nipocalimab in adults living with generalized myasthenia gravis (gMG) as well as the Phase 2 DAHLIAS study of nipocalimab in adults with Sjögren's disease (SjD).
Nipocalimab has demonstrated clinical effects in four autoantibody-driven diseases within the past year, including hemolytic disease of the fetus and newborn and rheumatoid arthritis, in addition to gMG and SjD.
In the Phase 3 VIVACITY study in gMG, nipocalimab met the primary endpoint, achieving a statistically significant reduction in MG-ADL score from baseline over weeks 22 to 24 compared with placebo.
gMG is an autoantibody-driven neuromuscular disease characterized by fluctuating muscle weakness.
The primary endpoint was also met in the Phase 2 DAHLIAS dose-ranging study in SjD with a statistically significant reduction in clinESSDAIb score from baseline at week 24 compared with placebo.
Sjögren's disease is an immune system disorder in which the body attacks its healthy cells that produce saliva and tears.
Nipocalimab was well-tolerated by participants in both studies.
In June 2023, the FDA approved Argenx SE's (NASDAQ: ARGX) subcutaneous (under-the-skin) injection, Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc), for treating gMG.
Nipocalimab and Vyvgart Hytrulo block a receptor called FcRn and help reduce overall levels of IgG, a type of antibody responsible for gMG.
Vyvgart Hytrulo is available in the U.S. at a list price of $15,773 and is expected to generate about $2.5 billion in revenue for the treatment of gMG alone, Reuters noted.
William Blair states that the recent findings validate the emergence of a new contender within the FcRn antagonist category, posing competition to argenx's Vyvgart in generalized myasthenia gravis.
This development was largely anticipated. Furthermore, these results have implications for the ongoing Phase 2 trial of efgartigimod in Sjogren's syndrome, with data anticipated in the first half of the current year.
Price Action: JNJ shares are down 0.32% at $156.11, and ARGX shares are up 7.49% at $407.21 on the last check Monday.