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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 pharmaceutical firm Bristol Myers Squibb, overnight into Friday.
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.
Cobenfy is an outstanding example of how science can drive forward more effective mental health treatments in our lifetimes— Dr Lynsey Bilsland, Wellcome
In the UK, the University of Oxford has said it will start a trial on the compound next year.
A spokesperson for Bristol Myers Squibb told the PA news agency it had only submitted the drug to the FDA so far but continued “to evaluate our opportunities outside of the US”.
Pharmaceutical companies frequently apply to the FDA for approval before other countries, including the UK.
Dr Lynsey Bilsland, head of mental health translation at Wellcome in the UK, which 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.
“Schizophrenia is commonly treated with antipsychotics.
“While these can be effective in managing symptoms like 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.
“Wellcome supports mental health research to drive transformation in early intervention for anxiety, depression and psychosis.
“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, and I am very excited about this— Dr Sameer Jauhar, senior clinical lecturer
Dr Robert McCutcheon, from the department of psychiatry at the University of Oxford, said: “This is a major advance – it is 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.
“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.
“We will be running the first UK trial of this compound in Oxford, starting in 2025.”
Dr Sameer Jauhar, senior clinical lecturer in affective disorders and psychosis, and consultant psychiatrist at King’s College, London and the Maudsley NHS foundation trust, said: “Schizophrenia can be a devastating illness for people and their families, and the effects on society are significant.
“We do have effective treatments, and the pharmacological treatments are a foundation for holistic care (which includes psychosocial interventions).
“Unfortunately, currently available antipsychotics have significant side-effects, which include weight gain and movement effects, and this can affect people’s concordance with treatment.
“All currently licensed antipsychotics exert effects on the dopamine system, and this has been the case for at least 50 years.
“We have had false dawns before, 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.
“In my opinion, as a clinician and researcher, this is possibly one of the most exciting developments in our field, and I am very excited about this.”
Schizophrenia is a severe, long-term mental health condition that affects about one in 300 people across the globe.
