FDA approves Vyvgart for treatment of myasthenia gravis

The FDA announced the approval of Vyvgart for treatment of the chronic autoimmune, neuromuscular disease myasthenia gravis in adults who are positive for acetylcholine receptor antibody.

The approval of the investigational antibody fragment designed to target the neonatal Fc receptor is the first for the new drug class, according to a press release.

“There are significant unmet medical needs for people living with myasthenia gravis, as with many other rare diseases,” Billy Dunn, MD, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in the press release. “Today’s approval is an important step in providing a novel therapy option for patients and underscores the agency’s commitment to help make new treatment options available for people living with rare diseases.”

In a randomized, double-blind, placebo controlled, multicenter Phase 3 trial completed in 2020, patients with myasthenia gravis with acetylcholine receptor antibodies who received Vyvgart (efgartigimod, Argenx) responded to treatment at a higher rate as compared with placebo.

Since the therapy reportedly decreases levels of immunoglobulin, experts warn of an increased risk of infection. Hypersensitivity reactions are also possible, including eyelid swelling, shortness of breath, and rash. In the cases of hypersensitivity or existing infection, treatment should be either discontinued or delayed, according to the press release.