Bristol Myers Squibb’s drug Cobenfy
Courtesy: Bristol Myers Squibb
The Food and Drug Administration on Thursday approved Bristol Myers Squibbit is very expected schizophrenia drug Cobenfy, the first new type of treatment for the debilitating, chronic mental disorder in more than seven decades.
Schizophrenia it affects how a person thinks, feels and behaves and can cause paranoia, delusions, hallucinations and changes in feelings, movements and behaviour. These symptoms can disrupt the patient’s daily life, making it difficult to go to school or work, socialize, and complete other daily activities. Most people are diagnosed with their late teens to early 30s.
Bristol Myers Squibb expects the twice-daily pill, which will be sold under the brand name Cobenfyit will be available in late October, executives told CNBC. The drug is a much-needed new option for the nearly 3 million adults in the U.S. living with schizophrenia, some medical experts say.
Only 1.6 million of these patients receive treatment for the condition, and 75% of them stop taking existing drugs in the first 18 months because they struggle to find treatments that are effective or easily tolerated, according to the pharmacist.
Cobenfy could also be a huge long-term sales opportunity for Bristol Myers Squibb, which is under pressure to offset the potential loss of revenue from top-selling treatments that will see their patents expire. The drug comes from the company’s massive $14 billion acquisition of biotech company Karuna Therapeutics late last year.
In a July research note, Guggenheim analysts said they see Cobenfy as a “multi-billion dollar long-term opportunity” for the company. However, they said the drug will likely have a slow rollout, so it may not contribute significantly to Bristol Myers Squibb’s top line in 2024 and 2025.
“I think there’s potentially a really transformative moment in how we treat and talk about schizophrenia. And what you have is, unfortunately, an often underserved population that doesn’t get the attention it deserves in terms of research and health care ” Andrew Miller, founder and former president of research and development at Karuna Therapeutics and now a consultant at Bristol Myers Squibb, told CNBC.
“I think the most important moment will be five or ten years from now when we look back and say we really made a difference,” he continued. “We’ve helped people, we’ve improved outcomes, we’ve given caregivers and doctors another tool they can use.”
Cobenfy will cost $1,850 for a month’s supply, or $22,500 a year before insurance and other discounts, Bristol Myers Squibb executives said.
They said pricing is in line with existing brand-name oral schizophrenia treatments and that they expect most patients, particularly those enrolled in Medicare and Medicaid, to have minimal costs for the drug. About 80% of patients living with the condition are covered by government insurance, according to Bristol Myers Squibb.
The company plans to launch a program aimed at helping patients afford Cobenfy, executives added.
It’s not yet clear how much this program will increase access for people without insurance.
Cobenfy will have to compete with some existing schizophrenia drugs – called antipsychotic treatments – with lower list prices, especially generic copies of brand name treatments. For example, patients without insurance can get the generic version of an antipsychotic medication called Abilify for just $16 for 30 tablets once a day with free coupons from GoodRx.
Existing schizophrenia drugs work by directly blocking dopamine receptors in the brain to generally improve symptoms in patients.
But they come with a long list of serious potential side effects that can force patients to stop treatment, including weight gain, extreme fatigue and involuntary, uncontrollable movements. Roughly one third of the people with schizophrenia are also resistant to conventional antipsychotic treatments, according to WebMD.
Cobenfy is the first treatment approved in a new class of drugs that don’t directly block dopamine to improve the symptoms of schizophrenia, Dr. Samit Hirawat, chief medical officer of Bristol Myers Squibb;
He said part of Cobenfy is a drug called xanomeline, which activates certain so-called muscarinic receptors in the brain to reduce dopamine activity without causing the side effects associated with antipsychotics. The second part of Cobenfy is called trospio, which reduces the gastrointestinal side effects associated with xanomeline, such as nausea, vomiting, diarrhea and constipation.
“The majority of these patients have already cycled through one or two of these products,” Adam Lenkowsky, head of commercialization at Bristol Myers Squibb, told CNBC. “So the excitement we’re hearing from doctors is the opportunity to have a patient start treatment without seeing the side effects, but also have unprecedented efficacy.”
Lenkowsky said the company expects Cobenfy to eventually become the standard treatment for schizophrenia as doctors learn more about the drug and become more comfortable prescribing it to patients.
But the price could limit the drug’s use in patients who have already tried and failed other existing treatments, said Nina Vadiei, a clinical associate professor of pharmacotherapy and translational sciences at the University of Texas at Austin College of Pharmacy.
“If it were up to me, I wouldn’t necessarily say we should try X number of antipsychotics first. But I know from experience in a hospital setting that that’s probably what should happen because of cost, mostly.” said Vadiei, a clinical psychiatrist pharmacist who sees patients with schizophrenia at San Antonio State Hospital.
Test results and upcoming research
The approval was based on data from three clinical trials that compared Cobenfy with a placebo, as well as two longer-term studies that looked at how safe and tolerable the drug is for up to a year. Cobenfy met the primary goal of all three trials, a significant reduction in schizophrenia symptoms compared to a placebo, according to Bristol Myers Squibb.
In the studies, Cobenfy led to mostly mild to moderate side effects, which were mostly gastrointestinal and went away over time, Miller said.
Bristol Myers Squibb said Thursday’s schizophrenia approval could be just the beginning for Cobenfy.
For example, the company has ongoing late-stage clinical trials examining Cobenfy’s potential in treating Alzheimer’s disease patients with psychosis. Bristol Myers Squibb said it expects to publish data from those studies in 2026.
The company also plans to study Cobenfy’s potential to treat bipolar mania and irritability associated with autism.
“When we think of Cobenfy, we think of it as multiple indications packed into one product … because we’re actually developing the drug not just for schizophrenia but six other indications,” Hirawat said, referring to other potential uses for the drug.
— CNBC’s Angelica Peebles contributed to this report.
