The Food and Drug Administration has approved Bristol Myers Squibb’s new schizophrenia drug, Cobenfy. This drug is the first novel type of treatment for schizophrenia in over seven decades. Schizophrenia is a chronic mental disorder that affects how a person thinks, feels, and behaves. The symptoms of schizophrenia can disrupt everyday life, making it difficult for patients to carry out daily activities. Most people are diagnosed in their late teens to early 30s. Cobenfy will be available in late October and is expected to be a much-needed new option for the 3 million adults in the U.S. living with schizophrenia.
The drug comes as a result of Bristol Myers Squibb’s acquisition of biotech company Karuna Therapeutics at the end of last year. Analysts view Cobenfy as a “longer-term multi-billion dollar opportunity” for the company. However, they believe the drug will have a slow launch and may not significantly impact Bristol Myers Squibb’s revenue until 2024 or 2025. The drug is priced at $1,850 for a month’s supply or $22,500 annually before insurance and other rebates. The company aims to help patients afford Cobenfy through a program, but it remains unclear how this will improve access for those without insurance.
Cobenfy is unique in that it is the first treatment approved from a new class of drugs that do not directly block dopamine to improve symptoms of schizophrenia. The drug activates certain muscarinic receptors in the brain to decrease dopamine activity without causing the side effects associated with antipsychotics. It also includes a component that reduces gastrointestinal side effects. Multiple clinical trials have shown that Cobenfy significantly decreases symptoms of schizophrenia compared with a placebo, with mostly mild to moderate side effects that dissipate over time. Bristol Myers Squibb has ongoing late-stage trials examining Cobenfy’s potential in treating Alzheimer’s disease, bipolar mania, and irritability associated with autism.
Bristol Myers Squibb expects Cobenfy to eventually become the standard treatment for schizophrenia as physicians become more familiar with the drug and its benefits. However, the price of the drug may limit its use to patients who have tried and failed with other existing treatments due to cost concerns. The company also has plans to study Cobenfy’s potential in treating various other conditions beyond schizophrenia, including Alzheimer’s disease, bipolar mania, and autism-related irritability. The approval of Cobenfy for schizophrenia marks just the beginning of the drug’s potential in treating a range of mental health conditions.
