FDA Approves Bristol Myers Squibb’s New Antipsychotic Drug Cobenfy for Schizophrenia Treatment

The U.S. Food and Drug Administration (FDA) has approved Cobenfy (xanomeline and trospium chloride), for the treatment of schizophrenia, a chronic mental health disorder. Developed by Karuna Therapeutics and now owned by Bristol Myers Squibb, Cobenfy works by targeting cholinergic receptors unlike traditional antipsychotic medications that target dopamine receptors.

This marks a significant departure from the conventional approach to schizophrenia treatment, according to the FDA. Schizophrenia is a debilitating mental illness characterized by hallucinations, delusions, disorganized thinking, and behavioral disturbances. Those affected often struggle to maintain a grasp on reality and may experience cognitive impairments.

Globally, about 24 million people are living with schizophrenia, including 2.8 million in the U.S., where it ranks as one of the top 15 causes of disability. Tragically, the condition is linked to a shortened lifespan, with approximately 5% of patients dying by suicide, the FDA noted.

The approval of Cobenfy is seen as a hopeful development for individuals affected by schizophrenia. “Schizophrenia is a leading cause of disability worldwide. It is a severe, chronic mental illness that profoundly impacts quality of life,” said Tiffany Farchione, Director of the Division of Psychiatry at the FDA’s Center for Drug Evaluation and Research. “This drug offers the first new approach to treating schizophrenia in decades, providing an alternative to previously prescribed antipsychotic medications.”

The effectiveness of Cobenfy was demonstrated in two clinical studies. Over a five-week period, patients’ symptoms were measured using the Positive and Negative Syndrome Scale (PANSS), a 30-item tool used to assess schizophrenia symptoms. Results showed that patients treated with Cobenfy experienced a significant reduction in symptoms compared to those on a placebo.

However, the FDA highlighted several side effects associated with the drug, including nausea, constipation, vomiting, increased heart rate, and diarrhea. Due to the risk of severe side effects, the agency advised against prescribing Cobenfy to patients with urinary retention, kidney, or liver disease.

Earlier this year, in March, Bristol Myers Squibb acquired Karuna Therapeutics for $14 billion, gaining exclusive rights to KarXT (Cobenfy). The company plans to launch the drug by the end of October, with a monthly cost of $1,850, or around $22,500 annually, according to Reuters.

Sales are projected to reach $2.5 billion in the U.S. by 2030. Bristol aims to provide insurance coverage for 80% of patients within the first 12 to 18 months of the drug’s release. To further assist patients, Bristol has introduced a support program called “COBENFY Cares.”

Take a deep breath, your smartphone could help measure blood oxygen levels at home [Details]

First, pause and take a deep breath.

When we breathe in, our lungs fill with oxygen, which is distributed to our red blood cells for transportation throughout our bodies. Our bodies need a lot of oxygen to function, and healthy people have at least 95% oxygen saturation all the time.

Conditions like asthma or COVID-19 make it harder for bodies to absorb oxygen from the lungs. This leads to oxygen saturation percentages that drop to 90% or below, an indication that medical attention is needed.

In a clinic, doctors monitor oxygen saturation using pulse oximeters — those clips you put over your fingertip or ear. But monitoring oxygen saturation at home multiple times a day could help patients keep an eye on COVID symptoms, for example.

In a proof-of-principle study, University of Washington and University of California San Diego researchers have shown that smartphones are capable of detecting blood oxygen saturation levels down to 70%. This is the lowest value that pulse oximeters should be able to measure, as recommended by the U.S. Food and Drug Administration.

The technique involves participants placing their finger over the camera and flash of a smartphone, which uses a deep-learning algorithm to decipher the blood oxygen levels. When the team delivered a controlled mixture of nitrogen and oxygen to six subjects to artificially bring their blood oxygen levels down, the smartphone correctly predicted whether the subject had low blood oxygen levels 80% of the time.

In a proof-of-principle study, University of Washington and University of California San Diego researchers have shown that smartphones are capable of detecting blood oxygen saturation levels down to 70%. The technique involves having participants place their finger over the camera and flash of a smartphone, which uses a deep-learning algorithm to decipher the blood oxygen levels from the blood flow patterns in the resulting video./Photo:Dennis Wise/University of Washington

“Other smartphone apps that do this were developed by asking people to hold their breath. But people get very uncomfortable and have to breathe after a minute or so, and that’s before their blood-oxygen levels have gone down far enough to represent the full range of clinically relevant data,” said co-lead author Jason Hoffman, a UW doctoral student in the Paul G. Allen School of Computer Science & Engineering. “With our test, we’re able to gather 15 minutes of data from each subject. Our data shows that smartphones could work well right in the critical threshold range.”

Another benefit of measuring blood oxygen levels on a smartphone is that almost everyone has one.

“This way you could have multiple measurements with your own device at either no cost or low cost,” said co-author Dr. Matthew Thompson, professor of family medicine in the UW School of Medicine. “In an ideal world, this information could be seamlessly transmitted to a doctor’s office. This would be really beneficial for telemedicine appointments or for triage nurses to be able to quickly determine whether patients need to go to the emergency department or if they can continue to rest at home and make an appointment with their primary care provider later.”

The team recruited six participants ranging in age from 20 to 34. Three identified as female, three identified as male. One participant identified as being African American, while the rest identified as being Caucasian.

To gather data to train and test the algorithm, the researchers had each participant wear a standard pulse oximeter on one finger and then place another finger on the same hand over a smartphone’s camera and flash. Each participant had this same set up on both hands simultaneously.

“The camera records how much that blood absorbs the light from the flash in each of the three color channels it measures: red, green and blue,” said Wang, who also directs the UC San Diego DigiHealth Lab. “Then we can feed those intensity measurements into our deep-learning model.”

Each participant breathed in a controlled mixture of oxygen and nitrogen to slowly reduce oxygen levels. The process took about 15 minutes. For all six participants, the team acquired more than 10,000 blood oxygen level readings between 61% and 100%.

“Smartphone light can get scattered by all these other components in your finger, which means there’s a lot of noise in the data that we’re looking at,” said co-lead author Varun Viswanath, a UW alumnus who is now a doctoral student advised by Wang at UC San Diego. “Deep learning is a really helpful technique here because it can see these really complex and nuanced features and helps you find patterns that you wouldn’t otherwise be able to see.”

 

Obesity drug may decrease type 2 diabetes risk: Study reveals

New York, Sep 12 (IANS) The risk of type 2 diabetes is more than halved by weekly injections of the new obesity drug semaglutide, which was recently approved in the US and has been provisionally approved in England, says a new study.

The researchers of the study, to be presented at the annual meeting of the European Association for the Study of Diabetes (EASD), said semaglutide reduces the future risk of diabetes by over 60 per cent in patients with obesity.

“Semaglutide appears to be the most effective medication to date for treating obesity and is beginning to close the gap with the amount of weight loss following bariatric surgery,” said researcher W. Timothy Garvey from the University of Alabama at Birmingham in the US.

diabetes

Obesity is known to increase the risk of type 2 diabetes at least six-fold and the team was interested in understanding whether semaglutide could reduce this risk. To learn more, they conducted a new analysis of the data from two trials of semaglutide.

In STEP 1, 1,961 overweight or obese participants received an injection of 2.4 mg of semaglutide or a placebo weekly, for 68 weeks.

STEP 4 involved 803 participants with overweight or obesity. All received weekly injections of 2.4 mg semaglutide for 20 weeks. They then either remained on semaglutide or were switched to placebo for the next 48 weeks.

In STEP 1 participants receiving semaglutide, 10-year risk scores for type 2 diabetes decreased by 61 per cent (from 18.2 per cent at week 0 to 7.1 per cent at week 68). This compares to a 13 per cent reduction in risk score for those given the placebo (17.8 per cent at week +0 to 15.6 per cent at week 68).

In the STEP 4 participants, the largest decreases in risk scores were seen in the first 20 weeks (from 20.6 per cent at week 0 to 11.4 per cent at week 20). In those who continued receiving semaglutide, the risk score decreased further to 7.7 per cent but in those who were switched to placebo, it rose to 15.4 per cent.