Bristol Myers Squibb has received the US Food and Drug Administration (FDA) approval for Cobenfy (xanomeline and trospium chloride) to treat schizophrenia in adults.
Cobenfy combines xanomeline, a dual muscarinic receptor agonist, with trospium chloride, a muscarinic receptor antagonist that does not cross the blood-brain barrier.
According to the US drugmaker, Cobenfy is the first new class of medicine in several decades and brings a new approach to treating schizophrenia.
The drug works with a unique mechanism of action by selectively targeting cholinergic receptors (M1 and M4) in the brain, rather than dopamine receptors (D2), which has been the standard of care.
Bristol Myers Squibb board chair and CEO Chris Boerner said: “Today’s landmark approval of our first-in-class treatment for schizophrenia marks an important milestone for the community.
“As we reenter the field of neuropsychiatry, we are dedicated to changing the conversation around serious mental illness, beginning with today’s approval in schizophrenia.”
The US FDA approved Cobenfy based on the data from the EMERGENT clinical programme, which includes three placebo-controlled efficacy and safety trials and two open-label trials.
The clinical trials evaluated the long-term safety and tolerability of the drug for up to one year.
In Phase 3 EMERGENT-2 and EMERGENT-3 trials, Cobenfy met its primary endpoint, showing statistically significant reductions of schizophrenia symptoms compared to placebo.
The improvement is measured by the Positive and Negative Syndrome Scale (PANSS) total score change from baseline to week five.
Cobenfy showed a 9.6-point reduction in PANSS total score in the EMERGENT-2 trial and an 8.4-point reduction in the EMERGENT-3 trial, compared to placebo.
Also, the drug showed a statistically significant improvement in illness in EMERGENT-2, as measured by the Clinical Global Impression-Severity (CGI-S) score, a secondary endpoint.
The safety and tolerability profile of Cobenfy has been established across acute and long-term trials in the EMERGENT programme.
Furthermore, Bristol Myers Squibb has launched the COBENFY Cares programme to support patients who have been prescribed Cobenfy.
FDA’s Center for Drug Evaluation and Research office of neuroscience division of psychiatry director Tiffany Farchione said: “Schizophrenia is a leading cause of disability worldwide. It is a severe, chronic mental illness that is often damaging to a person’s quality of life.
“This drug takes the first new approach to schizophrenia treatment in decades. This approval offers a new alternative to the antipsychotic medications people with schizophrenia have previously been prescribed.”
