Bristol Myers Gets US Nod for First New Schizophrenia Drug Type in Decades
- Millions of patients may benefit from new treatment approach
- Product puts Bristol ‘on the map’ beyond cancer therapies
Bristol Myers Squibb Co. gained US approval for the first new type of schizophrenia drug in seven decades, opening a fresh avenue of treatment for millions with the serious mental disorder.
The medication, to be sold under the name Cobenfy, gained Food and Drug Administration clearance Thursday to treat patients with the illness that often produces hallucinations and delusions.
The approval is a win for Bristol, which made a big bet when it agreed to buy Karuna Therapeutics for $14 billion last year to bring in the treatment. If commercially successful, the product could help Bristol answer difficult questions about its future as key drugs face stiff competition and new pricing pressure. Two of its biggest sellers — the blood-thinner Eliquis and cancer immunotherapy Opdivo — will lose patent exclusivity in the coming years.
The new schizophrenia treatment could change how investors think of a company largely known for cancer therapies, said Samit Hirawat, Bristol’s chief medical officer. The approval “puts us on the map that we’re not just an oncology company,” he said.
Analysts estimate the twice-daily pill, also known as KarXT, will generate $1 billion in annual revenue by 2027. The drug was cleared without a black box warning — the FDA’s strongest caution for severe side effects. All other antipsychotic treatments for schizophrenia carry such warnings, Jefferies analyst Akash Tewari said in a note Wednesday, and avoiding one would be “an important differentiator.”
Getting the government to pay for the drug will be critical to its success. About 80% of US schizophrenia patients get their health care through the Medicare or Medicaid health programs — a greater share than many other drugs, said Adam Lenkowsky, Bristol’s chief commercialization officer.
Bristol said the monthly wholesale acquisition cost for Cobenfy is $1,850, though how much patients pay out of pocket will vary based on factors like insurance coverage. Patients on Medicaid, for example, are expected to pay less than $10 for a month’s supply, the company said.
Schizophrenia typically shows up during the late teens and early 20s. Because the symptoms overlap with other conditions, like post-traumatic stress disorder or bipolar disorder, many patients are initially misdiagnosed. An estimated 2.8 million US adults and 24 million people worldwide have the condition.
New Approach
For decades, schizophrenia treatments largely focused on dopamine receptors that affect movement, emotions and the brain’s reward system. But many people don’t respond to those drugs, and due to side effects like weight gain and drowsiness, less than half of patients keep taking them.
Bristol’s treatment is part of a new class of drugs that have a different target — muscarinic receptors, which modulate brain circuits that are disrupted in patients with schizophrenia.
These new medicines have become attractive to large pharmaceutical companies that had largely abandoned treatments for mental illness after struggling to limit their side effects. AbbVie Inc. recently acquired Cerevel Therapeutics, which aims to develop medicines for Parkinson’s disease and schizophrenia, for about $9 billion. Neurocrine Biosciences Inc., another company using a similar approach to treat schizophrenia, released data last month showing its treatment didn’t measure up to Bristol’s.
Bristol’s drug is an example of the serendipity that can happen in drug development. Eli Lilly & Co. had been studying a related treatment in the 1990s for Alzheimer’s disease, but discontinued the work due to side effects.
Karuna’s scientists paired that drug with a medication for overactive bladder. The combination stimulates receptors inside the brain and blocks those outside, treating schizophrenia symptoms while limiting side effects. Bristol plans to test drug against more illnesses, including psychosis from Alzheimer’s disease and bipolar disorder.
“This truly has the potential to transform the neuropsychiatry landscape for the next decade,” Lenkowsky said.
— With assistance from Bill Haubert
Source: Bloomberg
Source: Bloomberg
