FDA Approves First-in-Class Schizophrenia Drug from BMS

The FDA has approved Cobenify, an oral medication for the treatment of schizophrenia in adults. Cobenify represents the first new class of schizophrenia medicine in several decades and introduces a fundamentally new approach to treating the illness.

“Today’s landmark approval of our first-in-class treatment for schizophrenia marks an important milestone for the community, where after more than 30 years, there is now an entirely new pharmacological approach for schizophrenia — one that has the potential to change the treatment paradigm,” said BMS CEO Chris Boerner. “As we reenter the field of neuropsychiatry, we are dedicated to changing the conversation around serious mental illness, beginning with today’s approval in schizophrenia.”

Schizophrenia is a persistent and often disabling mental illness estimated to impact approximately 2.8 million people in the United States. While the current standard of care can be effective in managing symptoms of schizophrenia, up to 60% of people experience inadequate improvement in symptoms or intolerable side effects during therapy.

Cobenify was developed by Karuna Therapeutics (where it was known as KarXT). Karuna was acquired by BMS in March of 2024. Said Boerner at that time, “We are excited to expand our neuroscience portfolio as we welcome Karuna to Bristol Myers Squibb. Importantly, this transaction aligns with our commitment to strengthening BMS’s growth profile in the latter half of the decade and beyond.” (Source: Bristol Myers Squibb Website, 18 March, 2024 and 26 September, 2024)