FDA Approves New Schizophrenia Treatment, Cobenfy, Offering Fresh Approach

The FDA has approved Bristol Myers Squibb's Cobenfy, the first new type of schizophrenia treatment in over 70 years. Schizophrenia disrupts thinking, feeling, and behavior, often leading to paranoia, delusions, and hallucinations. It typically strikes in late teens to early 30s, making daily life challenging.

Cobenfy, a twice-daily pill, is expected to be available by late October. It offers a fresh approach for the nearly 3 million U.S. adults with schizophrenia, only 1.6 million of whom are currently treated. Many stop existing medications within 18 months due to ineffectiveness or side effects.

Cobenfy's approval stems from Bristol Myers Squibb's $14 billion acquisition of Karuna Therapeutics. The drug could be a significant revenue booster, though its impact may take years to materialize.

The drug costs $1,850 per month or $22,500 annually before insurance. Most patients, especially those on Medicare or Medicaid, will likely pay little out-of-pocket. The company plans a program to aid affordability.

Existing schizophrenia drugs block dopamine receptors, often causing side effects like weight gain and involuntary movements. Cobenfy, however, activates muscarinic receptors to reduce dopamine activity without these side effects. It also includes trospium to mitigate gastrointestinal issues.

Physicians are enthusiastic about Cobenfy's potential to offer efficacy without side effects. However, its high price may limit its use to patients who have failed other treatments.