FDA Approves First New Schizophrenia Drug in Decades

On Sept. 26, the U.S. Food and Drug Administration (FDA) approved Cobenfy, the first new treatment for schizophrenia in nearly 30 years. Developed by Karuna Therapeutics, later acquired by Bristol Myers Squibb, Cobenfy targets the cholinergic system through muscarinic receptors, unlike existing drugs that focus on dopamine. This novel approach is generating excitement among doctors and patients.

In clinical trials, Cobenfy significantly reduced symptoms like hallucinations and paranoia, with fewer severe side effects than traditional treatments. While approved as a standalone therapy, further studies will assess its effectiveness alongside existing medications. Bristol Myers Squibb is also exploring Cobenfy’s potential for treating conditions such as Alzheimer ’s-related psychosis and bipolar mania. The drug will be priced at $1,850 per month, with insurance coverage expected for most U.S. patients.

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