The U.S. Food and Drug Administration (FDA) approved a novel antipsychotic schizophrenia drug late Thursday, marking the first new treatment in decades for the mental health condition that affects 1.8 percent of the U.S. adult population.
It is a major victory for market-driven medication development. Chris Boerner, board chair and chief executive officer at Bristol Myers Squibb (BMS)—the biopharmaceutical company that created the drug—called the FDA decision a "landmark approval" and "one that has the potential to change the treatment paradigm."
Up until now, antipsychotic drugs, which address symptoms like hallucinations and delusions, worked by blocking access to dopamine receptors, according to The New York Times. This mechanism, however, contributed to common side effects like weight gain, social withdrawal, cognitive impairment, and lack of motivation.
Cobenfy, the newly approved drug, indirectly influences dopamine levels. Unlike the standard approach of targeting dopamine receptors used by other schizophrenia drugs, Cobenfy targets the cholinergic receptors. The hope is that the new medication can provide similar effects on hallucinations and delusions as the current drugs on the market, while reducing side effects.
Gordon Lavigne, CEO of the nonprofit advocacy organization Schizophrenia and Psychosis Action Alliance, told Reason that the personal-social effects of Cobenfy "would be difficult to measure," but that "you can reasonably assume that someone is going to have more of an ability to engage in daily life, be social, and be part of the fabric of [their] family."
The cost of the Cobenfy is set to be in line with most other antipsychotic medications on the market. Adam Lenkowsky, chief commercialization officer for BMS, told the Times that its wholesale cost would be $1,850 a month.
This marks yet another free market win in the healthcare space over government-funded research. Since 2002, the National Institute of Mental Health (NIMH) has allocated more than $20 billion to the research of the neuroscience and genetics of diseases like schizophrenia. Yet little benefit has actually come to patients—even by the admission of the person who oversaw the explosion in funding. "I should have been able to help us bend the curves for death and disability," said Thomas Insel, who led the NIMH for 13 years. "But I didn't."
He's not alone. "As a schizophrenia researcher, I'm embarrassed to say we've spent literally billions of American taxpayer dollars on genetics, looking to understand what causes schizophrenia to help us develop new drugs for schizophrenia, and we have not been successful," Mark Weiser, the chief of the psychiatry division at the Sheba Medical Center in Tel Aviv, told the Times.
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