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FDA approves Bristol Myers Squibb's schizophrenia drug, the first new type of treatment in decades

The Food and Drug Administration on Thursday approved Bristol Myers Squibb 's highly anticipated schizophrenia drug Cobenfy, the first novel type of treatment for the debilitating, chronic mental disorder in more than seven decades.

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

Bristol Myers Squibb expects the twice-daily pill, which will be sold under the brand name Cobenfy, to be available in late October, executives told CNBC. The drug is a badly 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 those patients are treated for the condition, and 75% of them stop taking existing medications in the first 18 months because they struggle to find treatments that are effective or easy for them to tolerate, according to the drugmaker.

Cobenfy could also be a huge long-term sales opportunity for Bristol Myers Squibb, which faces 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 whopping $14 billion acquisition of biotech company Karuna Therapeutics at the end of last year.

In a July research note, Guggenheim analysts said they view Cobenfy as a "longer-term multi-billion dollar opportunity" for the company. But they said the drug will likely have a slow launch, so it may not meaningfully contribute to Bristol Myers Squibb's top line in 2024 and 2025.

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