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The United States Food and Drug Administration (FDA) has approved Bristol Myers Squibb’s new in-class therapy, Cobenfy, for the management of schizophrenia in adults. The drug makes history as the first novel pharmacological class in decades to be introduced that treats the condition.

In a statement, the drugmaker noted that Cobenfy, a combination of a muscarinic receptor agonist, xanomeline, and an antagonist that acts in peripheral tissues, trospium chloride, represented a unique approach to managing schizophrenia.

In the brain, the drug affects only the muscarinic M1 and M4 receptors. This makes it different from most antipsychotics because it doesn’t block dopamine D2 receptors.

According to Rishi Kakar, a key investigator of the drug. The approval of Cobenfy marks a pivotal advancement in schizophrenia treatment, as most previously approved medications have traditionally targeted the same primary brain pathways.

“By leveraging a novel pathway, Cobenfy offers a new option to manage this challenging condition.”

 

Rishi Kakar, MD, chief scientific officer, Segal Trials.

According to the World Health Organization (WHO), schizophrenia affects an estimated 24 million globally and ranks in the list of the top 15 main causes of disability in the world. The condition is characterized by impaired attention, memory lapses, and challenges in decision-making and concentration.

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Gordon Lavigne, CEO of the Schizophrenia and Psychosis Action Alliance, notes that people with schizophrenia often struggle to find a therapy that significantly improves their symptoms. He acknowledges that Cobenfy’s approval creates a completely “new option” to managing the condition.

The approval by the FDA is based on data from a series of clinical trials coded EMERGENT, which demonstrated that Cobenfy significantly reduced schizophrenia symptoms compared to an inactive comparator. The drug showed a 9.6- and 8.4-point reduction in Positive and Negative Syndrome Scale (PANSS) in two related trials, respectively, from baseline to week 5.

In a key secondary endpoint, there was an observed improvement in illness as assessed through the Clinical Global Impression-Severity (CGI-S) Score.

According to Bristol Myers-Squibb, typical adverse effects observed during the trial were mainly gastro-intestinal, including diarrhea, abdominal pain, dyspepsia, gastroesophageal reflux disease, nausea, and vomiting.

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