FDA authorizes the first novel schizophrenia therapy in decades

The FDA gave the green light to Bristol Myers Squibb’s much-anticipated schizophrenia drug Cobenfy, the first new chemical entity to treat the severe, chronic mental illness in more than 70 years.
Schizophrenia is an illness that changes thoughts, feelings, and behavior and may include paranoia, distrust, hearing voices, and other disturbances in emotions, movements, and behavior. Those symptoms can significantly affect a patient’s ability to attend school or work, interact with others, and perform other activities. The majority of patients are usually diagnosed in their late teens and early 30s.
Cobenfy, the pill to be developed by Bristol Myers Squibb will be marked twice daily and the company’s officials predict that the pill will be in the market by the end of October. Estimated state that the new medication is needed for approximately 2.9 million adults in the United States living with schizophrenia. Of those patients, only 1.6 million are managed for the condition and 75% of those stop taking their current medications in the first 18 months because they are unable to find treatments that work for them.

It could also be a massive long-term sale for Bristol Myers Squibb as it battles for ways to replace income from bestselling drugs that will lose patent protection.
In July, Guggenheim analysts said in a research note that they consider Cobenfy to be a future multi-billion-dollar value proposition for the firm. However, they explained that the drug will probably have a slow start, thus, the drug may not significantly increase Bristol Myers Squibb’s revenues in 2024 and 2025.
Cobenfy will retail at $1,850 for a month or $22,500 for a year, excluding insurance and other coups, according to the company.
The company stated that Schizophrenia Oral branded treatment is currently priced right, that most patients, and especially those accessing healthcare under Medicare and Medicaid, should not incur too many costs for this medication. Home treatment of the condition is taken by about 80% of patients through government-insured health facilities, as estimated by Bristol Myers Squibb.
The company also plans to introduce a programme that is expected to assist patients to fund the purchase of Cobenfy according to executives.
That means Cobenfy’s list price will need to be lower than those of some other schizophrenia medications, known as antipsychotic therapies, especially if they are generics of branded medications. For instance, if a patient has no insurance, they could obtain a generic form of an antipsychotic known as Abilify for as little as $16 for 30 once-daily tablets once attached to a GoodRx coupon.
Currently, available schizophrenia medications act on the dopamine receptors in the brain to augment symptoms on average in patients. Possible side effects can lead to the discontinuation of therapy; weight gain, fatigue, and dystonia.
Cobenfy is the first treatment that belongs to a completely new class of drugs that do not directly block dopamine to provide better symptomatic treatment of schizophrenia, Samit Hirawat, the chief medical officer at Bristol Myers Squibb, explained.

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