FDA approves Bristol-Myers Squibb’s schizophrenia drug

The Food and Drug Administration approved it on Thursday. bristol myers squibCobenfi, the long-awaited schizophrenia drug, is the first new type of treatment for the debilitating chronic mental disorder in more than 70 years.

Schizophrenia affects the way a person thinks, feels, and behaves and can cause paranoia, delusions, hallucinations, and changes in emotions, movements, and behavior. These symptoms can disrupt a patient’s daily life, making it difficult to go to school or work, socialize, and perform other daily activities. Most people are diagnosed in their late teens to early 30s.

Bristol-Myers Squibb plans to launch a twice-daily pill sold under the brand name Cobenfi in late October, executives told CNBC. Some medical experts say the drug is a much-needed new option for the roughly 3 million adults living with schizophrenia in the United States.

According to drug companies, only 1.6 million of these patients are being treated for the disease, and 75% of them do not receive treatment at first because they struggle to find treatments that work or are tolerable for them. Patients will stop taking their existing medications after 18 months.

Cobenfi could also represent a huge long-term sales opportunity for Bristol-Myers Squibb. The company faces pressure to offset potential revenue losses on top-selling treatments as patents expire. The drug is the result of the company’s massive $14 billion acquisition of biotechnology company Karuna Therapeutics late last year.

Guggenheim analysts said in a July research note that they view Cobenfi as a “long-term multibillion-dollar opportunity” for the company. But they said the drug’s launch is likely to be delayed and may not contribute significantly to Bristol-Myers Squibb’s sales in 2024 and 2025.

“I think there is a potentially huge moment of change in the way we treat schizophrenia and the way we talk about schizophrenia, and unfortunately it’s not getting enough attention from a research or medical perspective. There are many underprivileged people who can’t afford it,” Andrew said. Miller, founder and former president of research and development at Karuna Therapeutics and current advisor to Bristol-Myers Squibb, told CNBC.

“I think the most important moment is when we can look back five or 10 years from now and say we actually made a difference,” he continued. “We have helped people, improved treatment outcomes, and given caregivers and doctors another tool to use.”

Cobenfi costs $1,850 for one month, or $22,500 a year before insurance and other rebates, Bristol-Myers Squibb executives said.

They expect that pricing will be consistent with existing branded oral schizophrenia drugs and that most patients, especially those enrolled in Medicare and Medicaid plans, will have minimal out-of-pocket costs for the drug. He said he is doing so. According to Bristol-Myers Squibb, about 80% of people living with the disease are covered by government insurance.

The company plans to launch a program aimed at helping patients purchase Cobenfi, executives added.

It remains to be seen how much the program will increase access for the uninsured.

Cobenfi will have to compete at lower list prices with some of the existing schizophrenia drugs called antipsychotics, especially generic copies of brand-name treatments. For example, patients without insurance can use a free coupon from GoodRx to get a generic version of an antipsychotic treatment called Abilify for just $16 for 30 once-daily pills.

Existing schizophrenia drugs work by directly blocking dopamine receptors in the brain and generally improve symptoms in patients.

However, they come with a long list of serious potential side effects that can cause patients to discontinue treatment, including weight gain, excessive fatigue, and involuntary and uncontrollable movements. According to WebMD, about one-third of people with schizophrenia also resist traditional antipsychotic treatment.

Dr. Sumit Hirawat, chief medical officer at Bristol-Myers Squibb, told CNBC that Cobenfi is the first treatment approved in a new class of drugs that does not directly block dopamine to improve symptoms of schizophrenia. He said that.

He said that part of Cobenfi is a drug called zanomeline, which activates certain so-called muscarinic receptors in the brain, reducing dopamine activity without causing the side effects associated with antipsychotic drugs. The second part of Cobenfy is called trospium, which reduces the gastrointestinal side effects associated with zanomeline, such as nausea, vomiting, diarrhea, and constipation.

“The majority of these patients have already used one or two of these products repeatedly,” Adam Lenkowski, chief commercialization officer at Bristol-Myers Squibb, told CNBC. he said. “So the enthusiasm we’re hearing from physicians is the opportunity for patients to start treatment without experiencing side effects and at the same time get unprecedented benefits.”

Lenkowski said the company expects Cobenfi to eventually become a standard treatment for schizophrenia as doctors learn more about the drug and become accustomed to prescribing it to patients.

But the price limits the drug’s use to patients who have already tried and failed with other existing treatments, said Nina Badiei, a clinical associate professor of pharmacotherapy and translational science at the University of Texas at Austin College of Pharmacy. He said that there is a possibility that

“If it were up to me, I wouldn’t necessarily say I’d have to try X number of antipsychotics first. But my experience in the hospital is that I would probably have to do that, mainly because of cost. “I know that,” said Vadiay, a clinical psychiatric pharmacist who sees patients with schizophrenia at San Antonio State Hospital. ”

The approval was based on data from three clinical trials comparing Cobenfi with a placebo and two long-term studies that examined the drug’s safety and tolerability for up to one year. Bristol-Myers Squibb said Cobenfi met the primary goal of three trials, which was to significantly reduce symptoms of schizophrenia compared to a placebo.

In the study, Cobenfi caused mostly mild to moderate side effects, primarily gastrointestinal, that resolved over time, Miller said.

Bristol-Myers Squibb said Thursday’s schizophrenia approval may be just the beginning for Cobenfi.

For example, the company is conducting late-stage clinical trials investigating Cobenfi’s potential in treating Alzheimer’s patients with psychosis. Bristol-Myers Squibb said it plans to release data from these studies in 2026.

The company also plans to study Cobenfi’s potential to treat the mania and irritability of bipolar disorder associated with autism.

“When we think about Cobenfi, we think of it as multiple indications packed into one product, because we not only have schizophrenia, but six other indications. “We’re actually developing this drug,” Hirawat said, referring to other possible uses for the drug.

—CNBC’s Angelica Peebles contributed to this report.