December 2021
The FDA announced the approval of Vygart for treatment of the chronic autoimmune, neuromusucal disease myasthenia gravis in adults who are positive for acetylcholine receptor antibody positive adults.
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.”