FDA Approves Bristol Myers' Cobenfy (KarXT), First New Schizophrenia Drug in Seven Decades

Sep 26, 2024, 10:52 PM

The U.S. Food and Drug Administration has approved Cobenfy (KarXT), a new schizophrenia drug developed by Karuna Therapeutics and acquired by Bristol Myers Squibb in a $14 billion deal. This marks the first new type of treatment for the mental disorder since the 1950s. Cobenfy acts on M1/M4 muscarinic acetylcholine receptors, expanding the treatment landscape beyond traditional dopamine-targeted medications. The twice-daily oral pill appears to be effective in reducing symptoms of schizophrenia with milder side effects compared to existing therapies. This approval is seen as a monumental advancement in psychiatric drug development, offering a new option for the estimated 1.8 million people in the U.S. treated for schizophrenia, many of whom cycle through antipsychotics due to limited effectiveness or intolerable side effects.