FDA Approves Cobenfy After Bristol Myers Squibb's Karuna Acquisition

After years of stagnation in the treatment of schizophrenia, Bristol Myers Squibb (BMS) has achieved a milestone with the approval of a new drug resulting from its $14 billion acquisition of Karuna Therapeutics. The FDA has given the green light to KarXT, now named Cobenfy, marking a significant advancement in schizophrenia treatment. This drug is the first antipsychotic that targets cholinergic receptors rather than dopamine receptors, as explained in an FDA announcement.

Worldwide, around 24 million people suffer from schizophrenia, including approximately 2.8 million in the United States. However, only about 1.6 million of these U.S. patients receive treatment, which BMS’ Chief Medical Officer, Dr. Samit Hirawat, attributes to the severe side effects of existing medications. These side effects are so burdensome that around 70% of patients eventually discontinue their medication.

Current schizophrenia treatments often lead to adverse effects such as weight gain, movement disorders, and excessive sedation. In contrast, Cobenfy’s main side effects are nausea, vomiting, and constipation, which are temporary and manageable with common antiemetics, according to Adam Lenkowsky, BMS’ Chief Commercialization Officer.

While older medications for schizophrenia focus on dopamine receptors, Cobenfy selectively targets muscarinic receptors M1 and M4, which are linked to learning, memory, and cognition. This new approach addresses both the positive symptoms of schizophrenia—like hallucinations and delusions—and negative symptoms, such as diminished emotional expression and motivation.

BMS plans to market a month’s supply of Cobenfy at $1,850, or $22,500 annually, which aligns with the cost of other branded antipsychotics. Analysts at Leerink Partners and William Blair predict significant sales for Cobenfy, with peak U.S. sales potentially reaching $2 billion by 2030. If the drug gains approval for additional conditions such as Alzheimer’s disease, sales could soar to between $3 billion and $5 billion.

Analysts believe Cobenfy’s pioneering role in this new class of schizophrenia drugs, coupled with enthusiasm for a novel treatment modality, will drive strong early adoption. BMS’ neuroscience efforts have lately focused primarily on Zeposia for multiple sclerosis, but the company has a history in schizophrenia treatment with its atypical antipsychotic Abilify (aripiprazole), approved in 2002. The FDA’s approval of Cobenfy marks a significant return for BMS to this therapeutic area.

According to Lenkowsky, the acquisition of Karuna and the launching of Cobenfy represent a pivotal moment for BMS, re-establishing its presence in the schizophrenia treatment space. BMS plans to introduce Cobenfy to the market in about a month, aiming for availability by late October.

BMS has integrated Karuna’s commercialization team to support the drug’s launch. Recognizing the scarcity of new treatments for schizophrenia, BMS is prioritizing access to Cobenfy, emphasizing the importance of government-based payers in coverage. The response from insurers has been positive, and BMS anticipates gaining approximately 80% access to Cobenfy through Medicare and Medicaid within 12 to 18 months.

BMS will also engage in campaigns targeting both patients and healthcare providers to raise awareness about Cobenfy. Looking ahead, BMS’ broader neuroscience strategy includes ambitions in neurodegeneration, neuroinflammatory diseases, and neuropsychiatry. The company sees a connection between the approval of Cobenfy and its larger goals in neuroscience, with upcoming readouts expected in Alzheimer’s disease and bipolar mania over the next few years.

Additionally, BMS plans to start a program for autism irritability around the end of 2025 or early 2026, with results anticipated later in the decade. Dr. Hirawat emphasized that this is just the beginning of BMS’ journey in neuroscience.