The FDA on Thursday approved Bristol Myers Squibb’s new schizophrenia drug in one of the year’s most anticipated regulatory decisions.
The approval gives Bristol Myers a significant foothold in the neuroscience and psychiatry fields as it prepares to bring to market the first new schizophrenia drug in decades. It also marks a considerable win for the company during a particularly challenging year in which execs slashed $1.5 billion in costs, thousands of workers were laid off, and more than a dozen or so programs were cut from its pipeline.
BMS’ $14 billion acquisition last year of Karuna Therapeutics, which developed KarXT, is now likely to pay off in a big way.
The drug’s brand name is Cobenfy, and it will cost $1,850 for a 30-day supply, or $22,500 annually — which is in line with other branded oral antipsychotics, according to BMS. There will be no difference in price among the three available dose levels.
Chief commercialization officer Adam Lenkowsky told Endpoints News that the company projects “multibillion-dollar” peak yearly sales for Cobenfy, while analysts have estimated at least $6 billion per year. There are about 2.8 million potential patients in the US, according to Bristol Myers.
Adam LenkowskyHowever, the company doesn’t expect sales to take off right away. Between 85% and 90% of the schizophrenia market is covered by Medicare or Medicaid, according to Lenkowsky, which will likely limit patient access at first. “It’s going to take some time — around 12 to 18 months — to get critical, massive access,” Lenkowsky said.
He also said that Cobenfy is so thoroughly different from the current array of schizophrenia drugs in everything from mechanism of action to side effects that the change in the market may be gradual at first.
“Although there’s tremendous excitement in the community, we’re also upending decades of prescribing behavior with generic atypical” antipsychotics, Lenkowsky said. “We would expect that uptake to really happen in the back end of ‘25 and certainly well into ‘26 and beyond.”
BMS anticipates the drug being available in mid-October, though the company will treat it as a 2025 launch.
A new option
An important part of Cobenfy’s approval, according to Bristol Myers, is that it can be used regardless of whether patients have been previously treated with other schizophrenia drugs.
Andrew MillerMost, if not all, schizophrenia drugs approved in the last 70 years are based on dopamine and serotonin, and come with side effects related to those mechanisms like weight gain, said Andrew Miller, Karuna’s former president of R&D. While those drugs helped with the symptoms of psychosis, they didn’t do much for schizophrenia’s cognitive impacts. Cobenfy is an M1/M4-preferring muscarinic agonist that, unlike other schizophrenia medicines, doesn’t directly block dopamine receptors.
Miller, who currently serves as an advisor to Bristol Myers, said about 80% of schizophrenia patients usually switch or stop taking their medications after about 18 months. He also estimates between 60% and 80% patients are not satisfied with their current treatment regimens, making Cobenfy an appealing option.
“The options they have available to them are, right now, all treatments that look very similar to what they’ve already tried,” Miller said.
Though Cobenfy can be used as someone’s first option, there aren’t many schizophrenia patients who haven’t previously been treated. Miller and BMS expect the drug to eventually replace older antipsychotics and become the new standard of care.
More in store
Samit HirawatBMS isn’t planning on stopping at schizophrenia for Cobenfy. It currently hopes to broaden the drug’s use in at least six other indications, chief medical officer Samit Hirawat said.
The company has ongoing Phase 3 studies, including to treat psychosis brought on by Alzheimer’s disease and as an adjunctive treatment for schizophrenia. Both of those trials will likely read out near the end of 2025 or early 2026. Other Phase 3 trials expected to start next year include one for bipolar mania, Alzheimer’s-related agitation and Alzheimer’s related cognitive impairment.
A sixth Phase 3 trial, for autism-associated irritability disorder, is expected to start by early 2026, Hirawat said.