FDA Approves Vyvgart™ (efgartigimod) for Adults with Generalized Myasthenia Gravis

Last updated: December 2021

On December 17, 2021, the U.S. Food and Drug Administration (FDA) approved Vyvgart™ (efgartigimod) to treat generalized myasthenia gravis (gMG) in adults who test positive for the anti-acetylcholine receptor (AChR) antibody. Vyvgart is a new class of drug to be FDA-approved for this chronic autoimmune disease.1

About 85 percent of people with generalized MG have AChR antibodies. AChR antibodies disrupt the communication between nerves and muscles, resulting in muscle weakness. This new drug therapy will help to treat a large portion of the MG community.2

What are the ingredients?

The active ingredient in Vyvgart is efgartigimod alfa.3

How does it work?

Vyvgart is designed to stick to a protein known as the neonatal Fc receptor (FcRn). When Vyvgart binds to the FcRn, it stops FcRn from recycling antibodies back into the blood. This process reduces the circulation of AChR antibodies, which are responsible for interfering with nerve-muscle communication in people with MG.1,2

Evidence for Vyvgart

Vyvgart was tested in a 26-week randomized phase III clinical trial involving 167 people with MG. Half of the people were given Vyvgart. The other half were given a placebo (inactive drug).1

According to the study, 68 percent of people responded favorably to the drug, compared to the 30 percent who received a placebo. Those who took Vyvgart also showed improved muscle response compared to those who took the placebo.1

What are the possible side effects?

The most common side effects of Vyvgart include:1,2

  • Respiratory tract infection
  • Headache
  • Urinary tract infection

Some people in the clinical trial also reported hypersensitivity reactions, such as rashes, swelling under the skin, and shortness of breath. These side effects were generally mild and did not interrupt treatment with Vyvgart.2

These are not all the possible side effects of Vyvgart. Talk to your doctor about what to expect when taking this drug. You also should call your doctor if you have any changes that concern you when taking Vyvgart.

Other things to know

If you have a history of infection, share this information with your doctor before treatment with Vyvgart. People with an active infection should not receive Vyvgart.3

Because Vyvgart reduces antibody levels, you should not receive certain vaccines while taking this drug. Talk to your doctor about which vaccines should be avoided while being treated with Vyvgart.3

There is not enough data to know if Vyvgart is safe to take while pregnant or breastfeeding. If you are pregnant or breastfeeding, talk to your doctor before treatment with Vyvgart.3

Vyvagart was not studied in adults over the age of 65. It is not known whether they respond differently to treatment.3

Before beginning treatment with Vyvgart, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you take. This includes over-the-counter drugs.

For more information, read the full prescribing information of Vyvgart.

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