How Nipocalimab Could Change Myasthenia Gravis Care, with Andreia Pierce, Ph.D.

Generalized myasthenia gravis (gMG) is a chronic autoimmune disease mediated by immunoglobulin G (IgG) autoantibodies that affects approximately 700,000 people worldwide and 82,000 adults in the United States. It primarily impacts muscle function, leading to symptoms such as difficulty breathing or swallowing and muscle weakness. In severe cases, intubation may be necessary. Despite its serious nature, treatment options remain limited, and many therapies focus on symptom management rather than addressing the underlying immune dysfunction.

“There are still a number of unmet needs for this patient population,” says Andreia Pierce, Ph.D., MBA, head of US Autoantibody TA at Johnson and Johnson, in an interview with The Educated Patient.

Complicating matters further, gMG is a heterogeneous condition, meaning not all patients experience the same symptoms or respond to the same treatments. Some antibody subtypes may react well to available therapies, while others may not. Pierce says misdiagnosis and fluctuating symptoms further contribute to difficulties in disease management.

However, one promising investigational therapy for gMG is nipocalimab, an immunoselective treatment designed to lower IgG levels, which are a primary driver of autoantibody diseases. Unlike broader immunosuppressants, nipocalimab specifically targets IgG while preserving other immune functions. In the phase 3 Vivacity-MG3 study, patients receiving nipocalimab in combination with standard care experienced up to a 75% reduction in IgG levels, leading to improved symptom control over a 24-week period.

Recently, the U.S. Food and Drug Administration (FDA) granted priority review for nipocalimab for the treatment of gMG. Pierce explains that while some may misunderstand this designation as lowering regulatory standards, it does not alter the threshold for scientific rigor. Instead, it signifies that the FDA recognizes the therapy’s potential to provide significant improvements in efficacy, safety or prognosis. In the case of nipocalimab, its phase 3 study results suggest it could offer a meaningful advancement for this patient population.

With limited treatment options and ongoing unmet needs, Pierce and her team remain hopeful for more effective and accessible therapies. They continue to work passionately to develop solutions that go beyond symptom relief, aiming to improve long-term disease management and patient quality of life.