The US Food and Drug Administration said it has approved Bristol Myers Squibb'snew type of antipsychotic drug for treating schizophrenia, a chronic mental illness.
Unlike theusual dopamine- receptor-targeteddrugs,the Cobenfy (xanomeline and trospium chloride) capsule,targets cholinergic receptors, FDA said in a statement.
Schizophrenia is a mental health condition which leads to hallucinations, delusions, disorganized thinking and behavior. People with Schizophrenia struggle to live in the world of reality and often experience cognitive issues.
About 24 million people across the world, including2.8 million people in US are affected by schizophrenia. It is one of the 15 leading causes of disability in the country. People affected with the mental condition often die young, about five percent of them by suicide, according to FDA.
The approval is expected to help bring hopes in people affected with the mental condition, the health regulatory body said.
"Schizophrenia is a leading cause of disability worldwide. It is a severe, chronic mental illness that is often damaging to a person's quality of life," Tiffany FarchioneDirector of the Division of Psychiatry, Office of Neuroscience in the FDA's Center for Drug Evaluation and Research, said in a statement. "This drug takes the first new approach to schizophrenia treatment in decades. This approval offers a new alternative to the antipsychotic medications people with schizophrenia have previously been prescribed."
The effectiveness of the drug was tested in patientswho were part of two studies. During the five-week long study, clinicians measured symptoms with the help of the Positive and Negative Syndrome Scale (PANSS), a 30-item scaleused to measure symptoms of schizophrenia. Patients who used Cobenfy showed significant reduction in symptoms compared to the placebo group.
However, the drug was associated with some side effects like nausea, constipation, vomiting, increased heartbeat and diarrhea. Citing the severe side effects associated with Cobenfy, FDA cautioned against prescribing it to patients with urinary retention, kidney and liver disease.
It wasin March this year, Bristol Myers Squibb acquired Karuna Therapeuticsand ownership of its exclusive antipsychotic drug KarXT (xanomeline-trospium), or Cobenfyfor $14bn.
Bristol said it is planning to launch the drug by end of October. It will be priced at $1,850 a month or about $22,500 annually, Reuters reported. The sale of the drug is expected to generate $2.5 billion in U.S. by 2030, the report said. According to the news agency,Bristol is planning to cover 80 percent of its patients through different insurance plans in the first one to one and half years after the drug hits the market.
To support its patients, Bristol has also designed a program called 'COBENFY Cares.'the New Jersey based pharma company said.
* This is a contributed article and this content does not necessarily represent the views of btin.co.in