After decades of stagnation in the schizophrenia field, Bristol Myers Squibb’s $14 billion deal for Karuna Therapeutics has borne fruit with the approval of a promising new drug.
BMS’ first-in-class drug KarXT—now dubbed Cobenfy—won a landmark FDA approval Thursday to treat adults with schizophrenia. The medicine represents the first antipsychotic that targets cholinergic receptors as opposed to dopamine receptors, the FDA noted in a release.
Roughly 24 million people live with schizophrenia worldwide, with around 2.8 million people suffering from the ailment in the U.S., according to BMS.
But just 1.6 million of those U.S. patients are treated, BMS’ chief medical officer, Samit Hirawat, M.D., said in an interview. That's due in large part to the hefty side effect burden of current schizophrenia medicines on the market, he explained. Among the patients who are treated, around 70% eventually go off their medicines because of that side effect burden.
Side effects of current schizophrenia medicines include weight gain, movement disorders, excessive sedation and more, BMS’ chief commercialization officer, Adam Lenkowsky, added during the interview. By comparison, Cobenfy’s principal side effects are nausea, vomiting and constipation, which are transient and can be treated with common antiemetics, he explained.
While older schizophrenia meds target dopamine receptors, Cobenfy has a “selective impact” on the muscarinic receptors M1 and M4, which are associated with learning, memory and cognition, Hirawat explained. Compared with dopamine receptors, M1 and M4 receptors work on positive symptoms of schizophrenia—hallucinations and delusions—as well as negative symptoms, such as reduced emotional output, speech, motivation and pleasure, Lenkowsky pointed out.
BMS plans to price a month's supply of Cobenfy at $1,850 before discounts, or $22,500 per year, which is line with the cost of other branded antipsychotics, analysts at Leerink Partners wrote in a note to clients Friday.
In a separate note, analysts at William Blair predicted Cobenfy could achieve peak U.S. sales of roughly $2 billion in 2030, though that figure only accounts for the med's schizophrenia nod. Should Cobenfy pick up other indications in conditions like Alzheimer's disease, the med could see U.S. sales top out at a range of roughly $3 billion to $5 billion, the analysts said.
"We believe the first-mover advantage in this novel drug class for schizophrenia, meaningful enthusiasm around the availability of a new modality in schizophrenia, and favorable product profile for Cobenfy should support strong early adoption," the William Blair team added.
While BMS’ neuroscience presence has largely been limited to Zeposia in multiple sclerosis in recent years, the company does have a strong background in schizophrenia, as evidenced by the long run of the company’s own atypical antipsychotic Abilify (aripiprazole), which first won FDA approval in 2002.
In turn, the FDA approval of Cobenfy is a “full-circle moment,” Lenkowsky said.
“The acquisition of Karuna and, certainly, the launch of Cobenfy has allowed Bristol Myers Squibb to re-enter the space in an exceptionally meaningful way with an opportunity to help patients and caregivers who desperately need a new treatment,” Lenkowsky added.
BMS plans to bring Cobenfy to market about a month from now, with the product expected to be available in late October, he said.
As for the drug’s marketing campaign, “we’ve taken the entire Karuna commercialization team and shifted them over to BMS right upon the close,” Lenkowsky said. Given the dearth of novel schizophrenia treatments, BMS is putting access to its medicine front and center, Lenkowsky added, noting that government-based payers play a key role in coverage of schizophrenia medicines.
So far, the response from insurers has been “very positive,” Lenkowsky said. He explained that BMS expects to gain roughly 80% access to Cobenfy across Medicare and Medicaid within 12 to 18 months.
BMS will also be running engagement campaigns with both patients and doctors to spread the word about its new offering, the marketing chief said.
As for BMS’ broader neuroscience ambitions, which largely focus on neurodegeneration, neuroinflammatory diseases and neuropsychiatry, “there is a paucity and dearth of medicines” in those disease fields, Hirawat said. There's a “connectivity” between Cobenfy's FDA approval and the company’s larger neuroscience ambitions, Hirawat said, noting that readouts in Alzheimer’s disease agitation, Alzheimer’s cognition impairment and bipolar mania should come over the next few years.
The company is also planning to initiate a program in autism irritability toward the end of 2025 or early 2026, which is expected to read out during the back half of the decade, Hirawat said.
“The journey is just beginning,” BMS’ medical chief added.
Editor's note: This story has been updated with comments from analyst notes.