FDA approves Bristol Myers Squibb’s new schizophrenia drug

The US Food and Drug Administration (FDA) approved Bristol Myers Squibb’s on Thursday (BMY) highly anticipated anti-schizophrenia drug, Cobenfy. It is the first new treatment for the debilitating mental disorder in more than seven decades.

Since the 1950s, all treatments for schizophrenia 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, Cobenfyit consists of two components. The first is xanomeline, a drug that activates muscarinic receptors in the brain to reduce 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, director of the FDA’s drug center’s Division of Psychiatry, in a press release. “This drug is the first new approach to the treatment of schizophrenia in decades. This approval provides a new alternative to the antipsychotic drugs previously prescribed to people with schizophrenia.”

The FDA approved Cobenfy following two phase 3 studies. Over five weeks, patients who took Cobenfy twice a day saw a decrease of about 21 points in their PANSS (Positive and Negative Syndrome Scale) score – a scale used to assess the severity of symptoms in people with schizophrenia and other psychotic disorders – compared to 12 points. reduction in the placebo group.

The FDA warned Thursday that the drug should not be given to patients with liver failure because of the risk of liver damage. Other possible side effects include urinary retention, fast 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 percent of Americans have the disease, and globally it is one of the 15 leading causes of disability, according to the FDA. People with schizophrenia have a higher risk of dying at a younger age and nearly 5% die by suicide.

The US has launched a nationwide suicide and crisis hotline 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 around $22,500 per year.

Analysts at William Blair project that Cobenfy could reach peak US sales of around $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 $3 billion to $5 billion.