Johnson & Johnson has received approval from the Food and Drug Administration (FDA) to sell its drug Caplyta for treating major depressive disorder, also known as clinical depression. This is a significant step for the company, as they aim to make Caplyta a top-selling drug. Caplyta is already used to treat schizophrenia and bipolar I and II depression, which together affect around 13 million Americans. Clinical depression affects about 22 million Americans, and two-thirds of these patients do not find enough relief from current treatments. The FDA’s approval is based on research showing that Caplyta can greatly improve depression symptoms. In one study, 80% of patients responded to the treatment, and 65% achieved remission. Importantly, Caplyta did not cause common side effects like low sexual desire or weight gain, which often lead patients to stop taking antidepressants. This approval supports Johnson & Johnson’s recent purchase of Intra-Cellular Therapies, the company that developed Caplyta. The drug was first approved for schizophrenia in late 2019. Despite the challenges of the COVID-19 pandemic, Intra-Cellular launched Caplyta successfully with the help of TV commercials. After positive results in a late-stage clinical trial for depression in 2024, the company projected that Caplyta could bring in $5 billion annually. This acquisition was one of the largest in the industry this year. For Johnson & Johnson, this expanded use of Caplyta strengthens their lineup of brain-related drugs, including Spravato, a nasal spray form of ketamine used to treat depression. It also helps offset the loss of another experimental drug that did not meet expectations.