FDA official announcements and Bristol Myers Squibb press releases

FDA Approves Cobenfy, First New Schizophrenia Drug Since 1950s, Potentially Altering Treatment

Sep 26, 2024, 11:15 PM

The U.S. Food and Drug Administration (FDA) has approved Bristol Myers Squibb's Cobenfy (xanomeline and trospium chloride), previously known as KarXT, marking the first schizophrenia drug with a new mechanism of action since the 1950s. Cobenfy acts as a muscarinic agonist targeting the M1 and M4 muscarinic acetylcholine receptors, expanding treatment options beyond traditional dopamine-targeted antipsychotics. The drug offers improved efficacy in reducing schizophrenia symptoms with fewer and milder side effects, addressing a critical need as three-quarters of the 1.8 million adults in the U.S. treated for schizophrenia cycle through different antipsychotics due to inadequate symptom control or intolerable side effects. The approval is considered a monumental moment in psychiatric drug development, potentially altering how the disorder is treated. Bristol Myers Squibb acquired the drug through its $14 billion buyout of Karuna Therapeutics, and plans to market it as a twice-daily pill with a 30-day supply costing $1,850. While the launch may not accelerate until mid-2025, the company anticipates peak annual sales reaching $6 billion.