The FDA on Wednesday approved an antibody drug that developer Johnson & Johnson expects will eventually become one of its top-selling medicines.
The drug, which J&J will sell as Imaavy, was cleared by the FDA to treat adults and children 12 years of age or older who have an autoimmune condition known as generalized myasthenia gravis. The disease interferes with communication between nerves and muscles, leading to a diverse range of symptoms that can include fatigue, muscle weakness, difficulty breathing and changes in vision.
Imaavy is designed to lessen that interference by reducing levels of an immune system protein that mistakenly targets certain muscle receptors. In testing, treatment improved daily function versus placebo on a scale that assesses essential activities like talking, chewing and standing from a chair. Imaavy was also associated with an improvement in…