The FDA has cleared Bristol Myers Squibb’s new schizophrenia drug, Cobenfy. This was to be the very first completely new treatment for the chronic mental disorder in more than 70 years. It is going to be a good step forward for around 3 million adults in America suffering with schizophrenia-a psychological disorder that includes symptoms such as paranoia and hallucinations along with delusions.
Cobenfy will be ready as a twice-daily pill by late October. Despite the high demand for effective treatment options, only 1.6 million people are currently under treatment for schizophrenia, and 75% stop their medication in the first 18 months mainly because of problems in both tolerability and efficacy.
Bristol Myers Squibb believes Cobenfy could represent an exciting opportunity for significant revenues, especially as the company has bought Karuna Therapeutics for $14 billion to develop the drug. Analysts view Cobenfy as a multi-billion-dollar asset even if the market might enter slowly initially.
Andrew Miller is an advisory board member for Bristol Myers Squibb and the previous leadership member of Karuna Therapeutics. He recognized that Cobenfy is the “game-changer” in treating schizophrenia and said that the needs of many patients with this diagnosis can “fall through the cracks.” “I think we’ve helped people, improved outcomes, and provided caregivers and physicians with another tool,” he said.
Cobenfy, priced at $1,850 per month, or $22,500 a year, is about as expensive as any other of the branded schizophrenia medicines available. The company also plans to continue a program to help patients pay for the medication, since roughly 80% of schizophrenia patients rely on government insurance.
Notably, Cobenfy falls in the new class of drugs that do not function to block dopamine receptors, unlike the traditional drugs. Instead, this is the drug which combines xanomeline, a muscarinic receptor modulator with inhibitory effects on dopamine activity and trospium to prevent gastrointestinal side effects. For this reason, the approval of the medication is qualified by the fact that three clinical trials showed that it could significantly reduce the symptoms of schizophrenia.
Looking forward, Bristol Myers Squibb is also studying the possibility of Cobenfy’s use in diseases beyond this disease, such as Alzheimer’s disease and bipolar disorder, which implies this discovery could have a much larger impact.