A company called argenx has shared exciting news. The US Food and Drug Administration (FDA) has agreed to quickly review their request to expand the use of a medicine called VYVGART. This medicine is for adults with a specific type of muscle weakness disorder called acetylcholine receptor antibody seronegative generalised myasthenia gravis (gMG). The FDA aims to make a decision by 10 May 2026.
Dr. Luc Truyen, a top medical official at argenx, expressed hope. He said, “People with this type of gMG have few treatment choices. The FDA’s quick review shows that VYVGART could help them.”
Dr. Truyen added, “This step brings us closer to helping more people with muscle weakness disorders. We look forward to working with the FDA as they review our request.”
This request is based on results from a study called ADAPT SERON. It tested VYVGART in adults with this specific type of gMG. The study showed that VYVGART helped people improve their daily activities compared to a placebo after four weeks.
In the study, people taking VYVGART saw a significant improvement in their ability to do daily tasks. They also showed improvements in other measures of muscle strength. The medicine was well-tolerated, with no new safety concerns.
This news gives hope to people with this specific type of muscle weakness disorder, offering a potential new treatment option.