FDA approves Cobenfy (Picture credit: Reuters/Bristol Myers Squibb)

The US Food and Drug Administration (FDA) has approved Bristol Myers Squibb’s new oral medicine, Cobenfy, for the treatment of schizophrenia in adults. This approval marks the first new type of schizophrenia medicine in several decades that reduces the mental illness symptoms without the common side effects.
“Today’s landmark approval of our first-in-class treatment for schizophrenia marks an important milestone for the community.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 Chris Boerner, board chair and CEO of Bristol Myers Squibb. “As we reenter the field of neuropsychiatry, we are dedicated to changing the conversation around serious mental illness, beginning with today’s approval for schizophrenia.”
Bristol Myers Squibb plans to make Cobenfy, a twice-daily pill, available by late October. The drug will cost $1,850 per month, or $22,500 annually, before insurance and rebates.

Schizophrenia affects around 2.8 million people in the United States, impacting how they think, feel, and behave. Symptoms of Schizophrenia usually appear in early adulthood and vary greatly among individuals, making the condition hard to diagnose and manage. Current treatments can be effective, but up to 60% of patients find them inadequate or experience intolerable side effects.
“For people living with schizophrenia, it’s often difficult to find a treatment that works for them. Having a variety of treatment options gives patients and healthcare providers the tools to help manage this serious condition,” said Gordon Lavigne, CEO of the Schizophrenia & Psychosis Action Alliance. “People living with schizophrenia want and deserve more. Today’s approval provides a new option as people with schizophrenia move forward with proper support to rebuild their lives.”