The FDA just approved Bristol Myers Squibb's groundbreaking schizophrenia treatment
The U.S. Food and Drug Administration (FDA) on Thursday approved Bristol Myers Squibb’s (BMY) highly anticipated schizophrenia drug, Cobenfy. It’s the first novel treatment for the debilitating mental disorder in over seven decades.
Since the 1950s, all schizophrenia treatments have focused on targeting dopamine receptors. However, this approach has been linked to side effects such as sedation, weight gain, and motor impairment.
Bristol Myers Squibb’s new drug, Cobenfy, is made up of two components. The first is xanomeline, a drug that activates muscarinic receptors in the brain to lower dopamine activity without triggering the typical side effects of antipsychotics. The second component is trospium, which helps minimize gastrointestinal side effects associated with xanomeline, such as nausea, vomiting, diarrhea.
“Schizophrenia is a leading cause of disability worldwide,” said Tiffany Farchione, the director of the Division of Psychiatry in the FDA’s drug center, in a press release. “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.”
The FDA approved Cobenfy following two phase 3 trials. Over five weeks, patients taking Cobenfy twice daily saw about a 21-point drop in their Positive and Negative Syndrome Scale (PANSS) score — a scale used to assess symptom severity in individuals with schizophrenia and other psychotic disorders — compared to a 12-point reduction in the placebo group.
The FDA warned on Thursday that the drug shouldn’t be given to patients with liver impairment due to the risk of liver damage. Other possible side effects include urinary retention, rapid heart rate, reduced digestion, and facial swelling. The most common side effects were nausea, indigestion, constipation, vomiting, high blood pressure, stomach pain, diarrhea, fast heartbeat, dizziness, and acid reflux.
About 1% of Americans have this illness and globally it is one of the 15 leading causes of disability, according to the FDA. Individuals with schizophrenia are at greater risk of dying at a younger age, and nearly 5% die by suicide.
The U.S. launched a nationwide Suicide and Crisis Lifeline in 2022. Those in crisis can call or text 988, or reach the Crisis Text Line by texting TALK to 741741.
Cobenfy is expected to launch in late October with a list price of about $22,500 a year.
Analysts at William Blair project that Cobenfy could achieve peak U.S. sales of approximately $2 billion by 2030 for the treatment of schizophrenia alone. However, if ongoing phase 3 trials for additional indications, including Alzheimer’s-related psychosis and adjunctive schizophrenia, produce positive results, annual sales could reach between $3 billion and $5 billion.
Bristol Myers Squibb stock is up over 2%, as of Friday morning.
