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British scientists have hailed the US approval of a new drug for schizophrenia, saying it “has the potential to change the lives of millions of people”.
The “major advance” in treatment offers a completely new drug approach to treating the condition, which can cause terrifying hallucinations, delusional thoughts and social withdrawal.
The US Food and Drug Administration (FDA) has approved the new drug Cobenfy, which is owned by American pharmaceutical firm Bristol Myers Squibb.
The FDA’s approval was based on data from two studies showing patients experienced fewer schizophrenia symptoms.

The drug is the first approved antipsychotic to target receptors in the brain and body associated with the cholinergic neurotransmitter system, which has a key role in learning and memory, digestion, control of heartbeat, blood pressure, movement, and other functions.
In the UK, the University of Oxford has said it will start a trial on the compound in 2025.
A spokesperson for Bristol Myers Squibb said it had only submitted the drug to the FDA so far but continued “to evaluate our opportunities outside of the US”.
Dr Lynsey Bilsland, head of mental health translation at Wellcome, an independent global charitable foundation in the UK that funded early studies into Cobenfy, said: “It works in a completely different way from any other currently used schizophrenia drugs. It has the potential to change the lives of millions of people.”
While schizophrenia is commonly treated with antipsychotics, which can be effective in managing symptoms such as hallucinations and delusions, they do not address other life-limiting symptoms such as social withdrawal and memory problems.
“Cobenfy has the potential to address all of the above symptoms and also has fewer side effects, such as sleepiness and weight gain, and therefore could be game-changing, especially for those for whom other drugs do not work,” Bilsland said.
“Cobenfy is an outstanding example of how science can drive forward more effective mental health treatments in our lifetimes.”
In my opinion, as a clinician and researcher, this is possibly one of the most exciting developments in our field
Dr Sameer Jauhar, senior clinical lecturer in affective disorders and psychosis, King’s College London
Dr Robert McCutcheon, from the University of Oxford’s department of psychiatry, called the drug a major advance – “the first treatment for schizophrenia with a novel target for 70 years”.
“Current treatments are ineffective for many of the symptoms of schizophrenia – we need compounds with novel mechanisms of action,” he said.
“All other treatments work by targeting dopamine receptors. This is the first treatment that has a different target.
“We hope this may mean it can help people who don’t respond to standard treatments.”
Dr Sameer Jauhar, senior clinical lecturer in affective disorders and psychosis at King’s College London, said: “Schizophrenia can be a devastating illness for people and their families, and the effects on society are significant.”
Jauhar, who is also a consultant psychiatrist at the South London and Maudsley NHS Foundation Trust, added that effective treatments are available, and the drugs used are a foundation for holistic care that includes psychosocial interventions – activities used to modify behaviour, emotional state or feeling.
“Unfortunately, currently available antipsychotics have significant side effects, which include weight gain and movement effects,” he said, noting this can affect patients’ willingness to stick with agreed treatment.
“All currently licensed antipsychotics exert effects on the dopamine system, and this has been the case for at least 50 years.”
Jauhar said that there have been “false dawns” before, and that despite significant efforts in the field – with significant financial investment – phase-three trials of newer compounds have so far been disappointing.
“This novel treatment is the first of its kind, which does not act directly on the dopamine system, with good phase-three trial data,” he said.
“In my opinion, as a clinician and researcher, this is possibly one of the most exciting developments in our field.”
Schizophrenia is a severe, long-term mental health condition.
In Hong Kong, the Hospital Authority says it affects about 1 per cent of the local population. The World Health Organization estimates that it affects about 24 million people, or 1 in 300 people, worldwide. People with schizophrenia have a life expectancy 10 to 20 years below that of the general population.
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Cobenfy is the first schizophrenia drug in decades to treat the mental health condition in a new way, with potentially fewer side effects


Cobenfy is the first schizophrenia drug in decades to treat the mental health condition in a new way, with potentially fewer side effects.


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Disease

Mental health