Breakthrough in Schizophrenia Treatment! BMS Acquires Karuna for $14 Billion: New Drug Cobenfy Approved by FDA, Side Effects Only One-Tenth of Old Drugs!

After decades of stagnation in the field of schizophrenia treatment, Bristol Myers Squibb (BMS) announced the successful acquisition of Karuna Therapeutics for $14 billion, And with it came a significant breakthrough: regulatory approval of a new drug. BMS 'leading drug, karxt, now renamed cobenfy, officially received landmark approval from the U.S. Food and Drug Administration (FDA) on Thursday for the treatment of schizophrenia in adults. cobenfy is the first antipsychotic drug to target cholinergic receptors rather than traditional dopamine receptors, marking an innovation in treatment strategy.

According to the BMS, about 24 million people worldwide suffer from schizophrenia, including nearly 2.8 million in the United States. However, Samit Hirawat, MD, chief medical officer at BMS, revealed in an interview that only about 1.6 million of these U.S. patients have been treated. He further analyzed that the main reason for the low treatment penetration rate is the severe side effects that are prevalent in the current market of schizophrenia drugs, resulting in about 70% of patients eventually discontinuing treatment due to unbearable side effects.

Adam Lenkowsky, chief commercialization officer of BMS, added in an interview that the current side effects of the drug include weight gain, movement disorders and excessive sedation, emphasizing that the main side effects of cobenfy, such as nausea, vomiting and constipation, are transient and can be effectively alleviated with conventional antiemetic drugs.

Dr. Hirawat explained cobenfy's mechanism of action in detail, noting that unlike older drugs that target dopamine receptors, cobenfy has a "selective effect" on muscarinic receptors M1 and M4, which are closely related to learning, memory and cognitive function. Mr. Lenkowsky further noted that M1 and M4 receptors showed positive effects compared to dopamine receptors in alleviating both positive symptoms of schizophrenia (such as hallucinations and delusions) and negative symptoms (such as decreased affective expression, speech, motivation, and pleasure).

While BMS's neuroscience focus in recent years has been on the multiple sclerosis treatment Zeposia, the company also has a strong history in schizophrenia, as evidenced by its own atypical antipsychotic Abilify (aripiprazole), first approved by the FDA in 2002.

Mr. Lenkowsky described the FDA's approval of cobenfy as an important milestone in BMS's "return to its original purpose," emphasizing that the acquisition of Karuna and the subsequent launch of cobenfy not only mark BMS's return to the field of schizophrenia in a new light, but also bring hope to patients and healthcare professionals who urgently need new treatment options.

BMS plans to launch the marketing of cobenfy within a month and expects the product to be officially available by the end of October. Noting that innovation in the field of schizophrenia treatment has historically been challenging, often relying on "serendipitous discovery" or "chance," Dr. Hirawat praised the dedication of scientists from Karuna to BMS, whose exceptional work has led cobenfy to not only pass emergency trials, It also lays a solid foundation for the future study of six potential indications.

Speaking about the marketing strategy, Mr. Lenkowsky revealed that BMS has integrated the Karuna commercialization team into its system, and emphasized that given the scarcity of new drugs for schizophrenia, BMS will focus on improving access to medicines, putting them at the heart of its efforts. In particular, he noted that government payers play a pivotal role in schizophrenia drug coverage. So far, BMS has received "very positive" feedback from insurers and expects Medicare and Medicaid to cover about 80 percent of cobenfy's treatment costs within the next 12 to 18 months.

In addition, BMS plans to promote its new product through a series of patient-physician interactions. As for the company's broader neuroscience goals, Hirawat said it will focus on areas such as neurodegenerative diseases, neuroinflammatory diseases and neuropsychiatry, all of which are currently suffering from "drug scarcity." He stressed the strong "connection" between cobenfy's FDA approval and the company's larger neuroscience vision, revealing that data on Alzheimer's disease agitation, Alzheimer's disease cognitive impairment, and bipolar mania will be released over the next few years.

BMS also plans to launch a research project on irritability in autism in late 2025 or early 2026, which is expected to be completed in the second half of this decade. "The journey has just begun," concludes BMS's medical director.