FDA Approves Cobenfy, First Novel Schizophrenia Drug in Decades

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FDA Approves Cobenfy, First Novel Schizophrenia Drug in Decades
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The FDA has approved Cobenfy (cobrenify), a new twice-daily pill developed by Bristol Myers Squibb, as the first novel treatment option for schizophrenia in over 70 years. The medication is expected to be available in late October with a monthly cost of $1,850.

The twice-daily pill, Cobenfy , is a badly needed new treatment option for the nearly 3 million adults in the U.S. living with schizophrenia.The Food and Drug Administration approved Bristol Myers Squibb 's highly anticipated schizophrenia drug, the first novel type of treatment for the debilitating, chronic mental disorder in more than seven decades.

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 whoppingIn a July research note, Guggenheim analysts said they view Cobenfy as a"longer-term multi-billion dollar opportunity" for the company.

"I think there's potentially a really transformational moment in how we treat and talk about schizophrenia. And what you have is, unfortunately, an often disadvantaged population that doesn't get the attention they deserve from a research and health-care perspective," Andrew Miller, founder and former president of research and development of Karuna Therapeutics and now an advisor to Bristol Myers Squibb, told CNBC.

Existing schizophrenia drugs work by directly blocking the dopamine receptors in the brain to generally improve symptoms in patients. "The majority of these patients have already cycled through one or two of these products," Adam Lenkowsky, Bristol Myers Squibb's chief commercialization officer, told CNBC."So the enthusiasm that we're hearing from physicians is the opportunity to have a patient go onto treatment without seeing the side effects but also getting unprecedented like efficacy.

In the studies, Cobenfy mostly led to mild to moderate side effects, which were mainly gastrointestinal and dissipated over time, Miller said.

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