FDA approves highly anticipated first-in-class drug for schizophrenia: BMS’ Cobenfy
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.
Repairing Fragmented Care with Value-Based Strategies with Dr. Kamal Golla
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.
What else you need to know
Cardinal Health intends to buy Integrated Oncology Network (ION), a physician-led independent community oncology network based in Nashville, Tenn., for $1.15 billion in cash. ION has more than 50 practice sites across 10 states, with more than 100 providers. Along with medical oncology and radiation oncology, ION also provides urology, diagnostic testing, and other ancillary services. According to a press release announcing the definitive agreement between the two organizations, ION practices will become members of Navista, Cardinal Health’s oncology practice alliance, and will gain access to Navista’s advanced analytics capabilities, as well as the PPS Analytics platform Cardinal acquired earlier this year as part of the $1.2 billion Specialty Networks acquisition. ION’s practice management and practice growth services will become part of Navista’s advanced services and technology suite. Cardinal Health noted that the transaction is subject to regulatory approval and other customary closing conditions but did not provide an anticipated closing date.
St. Louis-based Ascension reported a $1.8 billion operating loss and a $1.1 billion net loss for the fiscal year ending June 30. Ascension attributed a significant portion of the loss to the ransomware attack that occurred in May. Prior to that event, the health system reported a year-to-date operating loss of $79 million (compared with an operating loss of $1.2 billion reported for the same 10-month period of FY 2023).For FY 2023, Ascension reported an operating loss of $3 billion and a net loss of $2.7 billion. During May and June, after the attack, Ascension’s same facility volumes decreased between 8% and 12%, on average, compared with the same period in 2023, Healthcare Dive reported, noting that Ascension had been on track to see a year-over-year increase in patient revenue of 5.4%; instead, the increase was just 0.9%.
In related news, Moody’s lowered Ascension’s outlook from stable to negative, according to Becker’s Hospital Review, reflecting the health system’s challenges in improving operating cash flow margins to pre-pandemic levels. Becker’s noted that Ascension has an Aa2 rating with Moody’s, which reflects the completion of a substantial portfolio reduction by next year and the continuation of strong operating improvements before the attack.
Sanofi received two bids from private equity firms for its consumer health unit, Bloomberg News reported, citing people familiar with the matter. The bids were from PAI Partners and Clayton Dubilier & Rice. The Sanofi unit could be valued at $16.7 billion or higher, according to Reuters, and Bloomberg said Sanofi may choose to pursue a spinoff if neither bid is satisfactory. When the French pharmaceutical company announced last October that it intended to separate its consumer health unit in the fourth quarter of this year “at the earliest,” Sanofi said it planned to create a publicly listed entity based in France. Johnson & Johnson, Pfizer, and GSK have all spun off their consumer health units.
The FDA approved Sanofi and Regeneron Pharmaceuticals’ Dupixent (dupilumab) for certain patients with chronic obstructive pulmonary disease (COPD), making it the first biologic to gain approval in the U.S. for this patient population. Specifically, the drug is approved as an add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype. Dupixent was first approved by the FDA in 2017 as a treatment for eczema and has since been approved for several other conditions, including asthma.
The Senate voted unanimously Wednesday to hold Steward Health Care’s CEO, Dr. Ralph de la Torre, in criminal contempt for defying a subpoena to testify at a hearing held on Sept. 12 by the Senate Committee on Health, Education, Labor and Pensions (HELP). Multiple news outlets noted this is the first time since 1971 the Senate has referred a contempt charge for criminal prosecution. The matter will be referred to the U.S. Attorney for the District of Columbia.
In separate news, Steward Health announced on Saturday that Dr. de la Torre will resign, effective Oct. 1. Sen. Edward Markey, D-Mass., who chairs the HELP Subcommittee on Primary Health and Retirement Security, released a statementsaying that Dr. de la Torre’s resignation “is not enough.” He said Dr. de la Torre and his “corporate enablers” must all face accountability for allowing greed and mismanagement “to rot the financial security of an entire hospital system.
What we’re reading
7 Takeaways From a Fireside Chat with Providence’s Chief of Virtual Care. MedCity News, 9.22.24
Improvement Science And Value-Based Payment Models. Health Affairs, 9.20.24
