FDA approves Bristol Myers and Karuna's schizophrenia drug in psychiatric milestone

The FDA has granted approval to Bristol Myers Squibb’s (BMS) new schizophrenia drug, Cobenfy, marking a momentous regulatory decision this year. This approval positions BMS prominently in the neuroscience and psychiatry sectors as they prepare to introduce the first new schizophrenia medication in several decades. The achievement comes during a particularly tough year for BMS, characterized by substantial budget cuts, workforce reductions, and the streamlining of its drug development pipeline.

Last year's $14 billion acquisition of Karuna Therapeutics by BMS seems poised to yield significant returns, with KarXT—now branded as Cobenfy—slated to hit the market. Cobenfy will be priced at $1,850 for a 30-day supply, totaling $22,500 annually, in line with other branded oral antipsychotics. The cost remains consistent across its three available dosage levels.

Adam Lenkowsky, BMS’ Chief Commercialization Officer, shared with Endpoints News that the company anticipates Cobenfy to achieve “multibillion-dollar” annual sales, with analysts projecting potential revenue of at least $6 billion per year. There are approximately 2.8 million potential patients in the United States according to BMS estimates.

Nevertheless, the company does not foresee immediate high sales. Lenkowsky noted that Medicare or Medicaid covers 85% to 90% of the schizophrenia market, which might initially restrict patient access to Cobenfy. He expects widespread access to develop over the next 12 to 18 months. Lenkowsky also highlighted that Cobenfy’s unique mechanism of action and side effect profile, which starkly contrasts with existing schizophrenia drugs, might result in a gradual market adaptation.

Despite the enthusiasm within the medical community, the transition to prescribing Cobenfy may be slow due to entrenched habits surrounding generic atypical antipsychotics. Lenkowsky anticipates significant uptake toward the latter part of 2025 and extending well into 2026 and beyond. BMS plans to have Cobenfy available by mid-October, though it will be treated as a 2025 launch.

A key aspect of Cobenfy’s approval is its applicability irrespective of patients' prior treatment with other schizophrenia medications. Andrew Miller, Karuna’s former president of R&D and now an advisor to BMS, pointed out that most schizophrenia drugs approved in the past 70 years target dopamine and serotonin, often resulting in weight gain and other side effects. While these drugs address psychosis symptoms, they fall short on mitigating schizophrenia’s cognitive impacts. Cobenfy, as an M1/M4-preferring muscarinic agonist, does not directly block dopamine receptors, setting it apart from other treatments.

Miller noted that about 80% of schizophrenia patients usually discontinue or switch medications within 18 months, and between 60% and 80% are dissatisfied with their current treatments. This dissatisfaction positions Cobenfy as an attractive alternative. Although Cobenfy can be a first-line treatment, the majority of schizophrenia patients already have some treatment history. Miller and BMS foresee Cobenfy potentially supplanting older antipsychotics and becoming the new standard of care.

BMS’s ambitions for Cobenfy extend beyond schizophrenia. Samit Hirawat, BMS’s Chief Medical Officer, disclosed plans to expand the drug's application to at least six additional indications. Ongoing Phase 3 studies include using Cobenfy to treat Alzheimer’s-related psychosis and as an adjunctive treatment for schizophrenia, with results expected by late 2025 or early 2026. Further Phase 3 trials planned for the next year will explore its efficacy for bipolar mania, Alzheimer’s-related agitation, and cognitive impairment. Additionally, a trial for autism-associated irritability disorder is slated to start by early 2026.