Based on promising study results for treating myasthenia gravis (MG), the U.S. Food and Drug Administration (FDA) is fast-tracking its review for nipocalimab. The drug was given priority review designation, which means the FDA will review the application on an accelerated timeline, given the drug’s potential to improve treatment options for MG.

In the study, people who took nipocalimab along with a standard MG treatment had noticeable improvements in their daily symptoms. Researchers used the Myasthenia Gravis-Activities of Daily Living (MG-ADL) scale, which measures how much MG symptoms affect everyday tasks. Over six months, those who took nipocalimab improved by an average of 4.7 points on the 0-to-24 scale, while those who took standard treatment plus a placebo (a sugar pill with no active drug) saw smaller improvements.

“A 1- to 2-point change actually can be the difference between normal eating and frequent choking, or shortness of breath at rest and being on a ventilator,”​ said Dr. Katie Abouzahr, a vice president at Johnson & Johnson Innovative Medicine.

How Nipocalimab Works

Nipocalimab is a type of medicine called a monoclonal antibody, which blocks a specific protein in the body called the neonatal Fc receptor (FcRn). This helps reduce harmful autoantibodies — proteins that mistakenly attack connections between nerves and muscles in people with MG. By reducing these autoantibodies, nipocalimab may improve nerve-muscle communication and muscle weakness.

A Potential Option for People With MG

MG is a long-term autoimmune disease that weakens muscles, making daily activities like walking, talking, and swallowing difficult. Treatments like steroids, plasma exchange, and immune-suppressing drugs can help, but they don’t work well for everyone and can cause serious side effects.

If approved, nipocalimab could give people another treatment option, targeting the root cause of MG symptoms with fewer unwanted effects.

If you’re living with myasthenia gravis and have questions or concerns about your treatment plan, speak with your healthcare provider. They can advise you about newer treatment options and help you choose a plan that best meets your goals.

Learn more about treatment options for myasthenia gravis.

Find Your Team

MGteam is the social network for people living with myasthenia gravis and their loved ones. On MGteam, members come together to ask questions, give advice, and share their stories with others who understand life with MG.

Have you found a treatment approach that works well for you? Share your experience in the comments below, or start a conversation on your Activities page.