BMS Acquires Karuna for $14B: FDA Approves New Schizophrenia Drug with Fewer Side Effects

After years of limited progress in schizophrenia treatment, Bristol Myers Squibb (BMS) has announced a major development. The company successfully acquired Karuna Therapeutics for $14 billion, leading to the approval of a groundbreaking new drug. BMS’s leading drug, previously known as KarXT, has been renamed Cobenfy and has received landmark approval from the U.S. Food and Drug Administration (FDA) for treating adult schizophrenia. This approval marks a significant shift, as Cobenfy targets cholinergic receptors instead of the traditional dopamine receptors, representing a new approach in treatment.

Schizophrenia affects approximately 24 million people globally, with nearly 2.8 million cases in the United States. However, only about 1.6 million patients in the U.S. receive treatment, as mentioned by Dr. Samit Hirawat, BMS’s Chief Medical Officer. The low treatment rate is attributed to the severe side effects of existing medications, causing around 70% of patients to discontinue their use.

Adam Lenkowsky, BMS’s Chief Commercialization Officer, pointed out that current schizophrenia medications often result in side effects like weight gain, movement disorders, and excessive sedation. In contrast, Cobenfy’s primary side effects—nausea, vomiting, and constipation—are temporary and manageable with standard antiemetic drugs.

Dr. Hirawat elaborated on Cobenfy’s mechanism, highlighting its selective effect on muscarinic receptors M1 and M4, which are linked to learning, memory, and cognitive function. These receptors have shown promising results in alleviating both positive symptoms (hallucinations and delusions) and negative symptoms (reduced emotional expression, speech, motivation, and pleasure) of schizophrenia, compared to dopamine receptors.

While BMS has recently focused its neuroscience efforts on Zeposia for multiple sclerosis, the company has a long history in schizophrenia treatment, notably with its atypical antipsychotic Abilify (aripiprazole), which received FDA approval in 2002. The approval of Cobenfy marks a significant milestone, symbolizing BMS’s renewed commitment to schizophrenia treatment and offering new hope to patients and healthcare providers seeking better options.

BMS plans to launch Cobenfy within a month, aiming for availability by the end of October. Acknowledging the historical challenges in schizophrenia treatment, often driven by chance discoveries, Dr. Hirawat commended the dedicated efforts of scientists from both Karuna and BMS. Their work has not only led to the approval of Cobenfy but also established a foundation for exploring six additional potential indications.

Regarding the marketing strategy, Mr. Lenkowsky mentioned that BMS has integrated the Karuna commercialization team and will emphasize improving access to the new medication. Given the scarcity of new treatments for schizophrenia, BMS will prioritize making Cobenfy accessible, especially through collaboration with government payers. Positive feedback from insurers indicates that Medicare and Medicaid may cover about 80% of Cobenfy's treatment costs within the next 12 to 18 months.

BMS also plans to promote Cobenfy through patient-physician interactions. Looking ahead, Dr. Hirawat outlined BMS’s broader neuroscience goals, which include tackling neurodegenerative diseases, neuroinflammatory conditions, and neuropsychiatry, all areas with a current lack of effective drugs. He emphasized the connection between Cobenfy’s approval and BMS’s larger neuroscience vision, hinting at forthcoming data on Alzheimer's disease agitation, cognitive impairment, and bipolar mania.

In addition, BMS will initiate a research project on irritability in autism by late 2025 or early 2026, aiming for completion in the latter half of the decade. Dr. Hirawat concluded by stating that this is just the beginning of BMS’s journey in revolutionizing neuroscience treatments.