Bristol Myers Squibb Co (NYSE:BMY, ETR:RM, OTC:BMYMP) shares moved higher after the pharmaceutical company’s schizophrenia drug was approved by the Food and Drug Administration (FDA), marking the first new treatment to be approved for the mental illness in decades.
The company said its twice-daily pill, sold under the brand name COBENFY, will be available starting in October.
Schizophrenia, which impacts about 2.8 million Americans, disrupts a person’s ability to think clearly, manage emotions, and interact with others, often leading to delusions, hallucinations, and cognitive difficulties.
Because the symptoms present differently in each person, it is challenging to diagnose and treat.
Unlike existing therapies, Bristol Myers Squibb’s drug takes a new approach by targeting M1 and M4 receptors in the brain.
The FDA’s approval was supported by the EMERGENT clinical program, in which the drug showed significant symptom reduction in schizophrenia compared to placebo.
“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,” Bristol Myers Squibb CEO Chris Boerner said in a statement.
Gordon Lavigne, Schizophrenia & Psychosis Action Alliance CEO, added: “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.”
Shares of Bristol Myers Squibb added 2.6% at about $51 in early trade on Friday.