J&J immune disease drug shines in phase 3 trial

Feb. 6, 2024

Johnson & Johnson has announced promising results from its trials of nipocalimab in treating autoantibody-driven diseases, including generalized myasthenia gravis (gMG) and Sjögren's Disease (SjD).

In the phase 3 VIVACITY study, nipocalimab showed effectiveness in reducing MG-ADL scores in gMG patients. Similarly, the phase 2 DAHLIAS study demonstrated significant reductions in clinESSDAI scores compared to placebo in patients with SjD, offering hope for those grappling with this prevalent autoimmune disease lacking approved advanced treatments.

Generalized myasthenia gravis is a chronic autoimmune disorder causing muscle weakness due to the immune system attacking acetylcholine receptors. Symptoms include drooping eyelids, double vision, and difficulty swallowing. SjD primarily affects moisture-producing glands, resulting in dry eyes and mouth. It can also lead to systemic symptoms such as fatigue and joint pain. Both conditions require ongoing management to alleviate symptoms and improve quality of life.

The FDA has granted nipocalimab Fast Track and Orphan Drug designations. 

In 2020, J&J acquired nipocalimab from Momenta Pharmaceuticals for about $6.5 billion, aiming to enhance its portfolio for challenging autoimmune diseases. Nipoclimab belongs to a class of drugs called FcRn antibodies, which analysts at SVBLeerink have estimated could generate $20-25 billion in sales by 2030.