FDA approves highly anticipated first-in-class drug for schizophrenia: BMS’ Cobenfy
Darwin Research Group
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On Thursday, the Food and Drug Administration?approved?Bristol Myers Squibb’s Cobenfy (xanomeline and trospium chloride) for treating adults with schizophrenia.?
A first-in-class muscarinic agonist, Cobenfy, previously known as KarXT, is the first new pharmacological approach to treating schizophrenia since clozapine was approved in 1989, according to BioSpace. Unlike the current standard of care, Cobenfy targets cholinergic receptors rather than dopamine receptors, the FDA said in a?press release.?
The FDA estimated that approximately 1% of the U.S. population has schizophrenia. BMS said the illness affects about 2.8 million people in the U.S. and nearly 24 million worldwide.
According to Dr. Samit Hirawat, BMS’ chief medical officer, only around 1.6 million people in the U.S. who have schizophrenia are treated for the disorder, Fierce Pharma reported. Dr. Hirawat said one of the main reasons patients are not under treatment is that existing schizophrenia drugs have side effects that cause about 70% of people to stop using them.?
Side effects commonly associated with older schizophrenia treatments include weight gain, movement disorders, and excessive sedation, Adam Lenkowsky, BMS’ chief commercialization officer, noted, according to Fierce Pharma. Cobenfy also has side effects —?such as nausea, vomiting, and constipation — which, Lenkowsky said, are transient and can be treated with antiemetics.?
Cobenfy’s approval was supported by data from the EMERGENT clinical program.?
“Due to its heterogeneous nature, schizophrenia is not a one-size-fits-all condition, and people often find themselves in a cycle of discontinuing and switching therapies,” said Dr. Rishi Kakar, an investigator in the EMERGENT program. “The approval of Cobenfy is a transformative moment in the treatment of schizophrenia because, historically, medicines approved to treat schizophrenia have relied on the same primary pathways in the brain. By leveraging a novel pathway, Cobenfy offers a new option to manage this challenging condition.”?
BMS said the drug should be available in late October. The company plans to price Cobenfy at $1,850 for a one-month supply, or $22,500 per year, before discounts.?
Our Take: BMS gained Cobenfy when the company acquired Karuna Therapeutics for $14 billion. The definitive agreement between BMS and Karuna was announced in December, and the deal was finalized in March.?
Investment banking firm Cantor Fitzgerald said Cobenfy could achieve U.S. sales of $1 billion as early as 2026, Biopharma Dive reported, adding that analysts at Leerink Partners believe the drug will generate sales in excess of $3 billion by 2030.?
Analysts with Truist Securities said in a note shared with BioSpace that Cobenfy “has first mover advantage and is a least 2-3 years ahead of the competition.”
AbbVie could eventually be a rival, with its recently completed $9 billion acquisition of Cerevel Therapeutics. Cerevel, a spinout of Pfizer, is developing emraclidine, also a muscarinic drug, and anticipates having initial trial data by year-end, according to Biopharma Dive.?
BMS is also assessing the drug as a potential treatment for agitation associated with Alzheimer’s disease and for bipolar disorder, with plans to begin late-stage clinical trials for both conditions next year. And, the company is expecting results in 2026 from trials evaluating the drug in patients with psychosis associated with Alzheimer’s disease, Biopharma Dive reported.?
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While demand for specialty care has never been higher, this demand hasn't resulted in better coordination among PCPs. Can value-based care bridge the gap? Our guest, Dr. Kamal Golla, senior medical director for value transformation at Evolent, thinks so. In this episode of Health Care Rounds, explore the importance of value-based care and how it can create exceptional patient experiences and better outcomes. Watch us?here on YouTube or listen to Health Care Rounds wherever you get your podcasts.
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