FDA approves Bristol-Myers Squibb’s schizophrenia drug | Wilnesh News

The U.S. Food and Drug Administration approved Thursday Bristol-Myers SquibbHighly anticipated schizophrenia drugsIt is the first new treatment for debilitating chronic mental disorders in more than 70 years.

Schizophrenia Affects the way a person thinks, feels, and behaves and may lead to paranoia, delusions, hallucinations, and changes in mood, movement, and behavior. These symptoms can disrupt a patient’s daily life, making it difficult to go to school or work, socialize, and complete other daily activities. Most people are diagnosed with They are in their late teens to early thirties.

Bristol Myers Squibb executives told CNBC that the twice-daily pill is expected to be available by the end of October and will be sold under the brand name Cobenfy. This drug is a much-needed new option Some medical experts say nearly 3 million adults in the United States suffer from schizophrenia.

Only 1.6 million of these patients received treatment, and 75% stopped taking the drug According to the drugmaker, they abandoned existing drugs within the first 18 months because they had difficulty finding treatments that were effective or easily tolerated.

Cobenfy could also be a huge long-term sales opportunity for Bristol-Myers Squibb, which is under pressure to offset potential revenue losses from patent expirations on its best-selling treatments. The drug comes from the company’s $14 billion acquisition of biotech company Karuna Therapeutics late last year.

Guggenheim analysts said in a July research note that they view Cobenfy as a “long-term multi-billion dollar opportunity” for the company. But the drug may be slow to come to market, so it may not meaningfully contribute to Bristol-Myers Squibb’s revenue in 2024 and 2025, they said.

“I think there could be a really transformative moment in the way we treat and talk about schizophrenia. Unfortunately, what we’re dealing with are vulnerable populations that, from a research and healthcare perspective, don’t get the attention they deserve. ,” 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 10 years from now when we look back and say we actually made a difference,” he continued. “We help people, we improve outcomes, and we give caregivers and doctors another tool to use.”

Bristol-Myers Squibb executives said Cobenfy would cost $1,850 per month to supply and $22,500 per year, not including insurance and other rebates.

They said pricing is consistent with existing brand-name oral schizophrenia treatments and they expect most patients, particularly those enrolled in Medicare and Medicaid, to have minimal out-of-pocket costs for the drug. About 80% of patients with the disease are covered by government insurance, according to Bristol-Myers Squibb.

Executives added that the company intends to launch a program aimed at helping patients afford Cobenfy.

It’s unclear how much the program will increase access for the uninsured.

Cobenfy will have to compete with some existing schizophrenia drugs – called antipsychotic treatment – Lower price tags, especially for products that are counterfeit brand name treatments. For example, uninsured patients can get a generic version of antipsychotic medication called Abilify for as little as 30 tablets, once daily, $16 Comes with a free coupon from GoodRx.

Existing schizophrenia drugs work by directly blocking dopamine receptors in the brain, generally improving patients’ symptoms.

But 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, uncontrollable movements. approximately one third of the people People with schizophrenia are also resistant to traditional antipsychotic drug treatments, according to WebMD.

Dr. Samit Hirawat, Bristol-Myers Squibb’s chief medical officer, told CNBC that Cobenfy is the first approved new drug treatment that does not directly block dopamine to improve schizophrenia symptoms.

Part of Cobenfy is a drug called xanomeline, which activates certain so-called muscarinic receptors in the brain, reducing dopamine activity without causing the side effects associated with antipsychotics, he said. The second part of Cobenfy, called trospium, 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, chief commercial officer at Bristol-Myers Squibb, told CNBC. “So the enthusiasm we’re hearing from physicians is about giving patients the opportunity to receive treatment. , without seeing any side effects, and achieving unprecedented therapeutic effects.”

Lenkowsky said the company expects Cobenfy to eventually become a standard treatment for schizophrenia as doctors learn more about the drug and feel more comfortable prescribing it to patients.

But the price may limit the drug’s use to patients who have tried other existing treatments without success, said Nina Vadiei, a clinical associate professor of pharmacotherapy and translational sciences at the University of Texas at Austin School of Pharmacy.

“If it were up to me, I wouldn’t necessarily say we have to try Vadiei, a clinical psychiatric pharmacist who treats patients with schizophrenia, said.