Bristol Myers Squibb’s Novel Schizophrenia Drug Gains FDA Approval, Shares Surge

Bristol Myers Squibb has secured a major victory with the U.S. Food and Drug Administration (FDA) approving its innovative schizophrenia drug, Cobenfy, previously known as KarXT. This marks a significant breakthrough in the treatment of schizophrenia, as Cobenfy is the first new type of antipsychotic medicine approved in decades.

The FDA’s decision, announced late Thursday, sent Bristol Myers Squibb’s shares up over 6% in premarket trading on Friday. The company acquired Cobenfy through its $14 billion acquisition of Karuna Therapeutics last year, and it is counting on the drug to drive growth as patents on its blockbuster drugs Revlimid and Eliquis expire in the coming years.

Cobenfy stands out from existing antipsychotic medications due to its novel mechanism of action. Unlike traditional drugs that target dopamine receptors, Cobenfy focuses on cholinergic receptors, offering a new approach to treating both positive and negative symptoms of schizophrenia.

Experts believe that this unique mechanism could lead to significant benefits for patients. Clinical trials have shown that Cobenfy effectively reduces schizophrenia symptoms without causing common side effects associated with dopamine-targeting drugs, such as weight gain and movement disorders. Importantly, Cobenfy’s labeling does not include a warning about an increased risk of mortality in elderly patients, a concern associated with some other antipsychotics.

“This drug has the potential to be a game changer for schizophrenia patients,” said Alan Schatzberg, a psychiatry professor at Stanford University School of Medicine, highlighting the unmet need for effective treatments with fewer side effects.

Bristol Myers Squibb has priced Cobenfy at $1,850 per month, or about $22,500 annually, and expects to make it available to patients by late October. Analysts project that Cobenfy could achieve $2.5 billion in U.S. sales by 2030, positioning it as a potential blockbuster drug for the company.

Key Takeaways:

• Cobenfy is the first new type of antipsychotic medication approved for schizophrenia in decades.
• It targets cholinergic receptors, offering a novel approach to treatment with potential benefits over existing medications.
• Clinical trials have shown Cobenfy to be effective in reducing symptoms without causing common side effects associated with traditional antipsychotics.
• The FDA approval is a significant win for Bristol Myers Squibb, potentially boosting its future growth prospects.

The approval of Cobenfy marks a major step forward in the treatment of schizophrenia, offering hope for improved outcomes and a better quality of life for individuals living with this complex and often debilitating mental illness.