The U.S. Food and Drug Administration (FDA) on Thursday approved Cobenfy (xanomeline and trospium chloride), developed by Bristol-Myers Squibb (BMY, Financial), as the latest therapy for adult schizophrenia patients. Following the positive announcement, BMY shares surged about 6% in pre-market trading on Friday, offering a boost amid a year of subdued stock performance.
Bristol-Myers Squibb plans to launch Cobenfy at the end of October with a monthly price of $1,850, translating to approximately $22,500 annually.
Previously known as KarXT, the drug was added to Bristol-Myers Squibb (BMY, Financial) pipeline after the $14 billion acquisition of Karuna Therapeutics in March. Originally developed by Boston-based PureTech Health (PRTC), FDA approval will trigger milestone payments up to $29 million as part of agreements with Karuna and Royalty Pharma. This news also pushed PureTech Health shares up by as much as 5% in pre-market trading on Friday.
When Bristol-Myers Squibb signed the acquisition agreement with Karuna in December, Cobenfy was under FDA review, targeting an action date of September 26, 2024.
Unlike dopamine receptor-targeting schizophrenia treatments, Cobenfy is the first FDA-approved antipsychotic targeting cholinergic receptors. By avoiding dopamine receptor inhibition, Cobenfy reduces risks of side effects like movement disorders and metabolic syndrome, making it a safer option for patients intolerant to traditional medications.
Cobenfy works on cholinergic receptors, particularly the M1 and M4 types, instead of directly acting on the dopamine system. This mechanism could potentially enhance cognitive function and alleviate negative symptoms, which are challenging for current dopamine-blocking drugs.
The cholinergic system is closely linked to cognitive function and emotional regulation. By targeting cholinergic receptors, Cobenfy may improve cognitive function and negative symptoms, offering significant benefits for long-term schizophrenia patients, especially those with cognitive impairments and reduced social functioning.
"This medication represents the first new approach to schizophrenia treatment in decades," noted Tiffany Farchione, director of the FDA's Division of Psychiatry in the Office of Neuroscience. "This approval provides schizophrenia patients with a novel option beyond the long-standing antipsychotic drugs."
