Bristol Myers Squibb (BMS) has received FDA approval for Cobenfy, a first-in-class schizophrenia treatment developed through its $14 billion acquisition of Karuna Therapeutics. Unlike traditional antipsychotics that target dopamine receptors, Cobenfy focuses on cholinergic receptors M1 and M4, which play a key role in learning, memory, and cognition. This unique mechanism not only treats the positive symptoms of schizophrenia, such as hallucinations and delusions, but also addresses negative symptoms like reduced motivation and emotional expression. By avoiding the weight gain, movement disorders, and sedation associated with older treatments, Cobenfy aims to improve patient adherence and quality of life.

BMS plans to launch Cobenfy in October 2024, with a broad rollout expected to gain 80% access across Medicare and Medicaid within 12 to 18 months. The drug's milder side effect profile—limited to manageable nausea, vomiting, and constipation—has drawn positive feedback from insurers, ensuring smoother market access. BMS is also integrating Karuna’s commercial team to drive engagement with doctors and patients. With around 2.8 million Americans affected by schizophrenia and significant challenges in existing treatments, Cobenfy is positioned to meet a critical need in the market.

The approval of Cobenfy represents a pivotal moment in BMS’ broader neuroscience strategy, which extends beyond schizophrenia to neurodegeneration, neuroinflammatory diseases, and bipolar disorders. BMS is exploring six additional indications for Cobenfy and has plans to initiate clinical programs for autism irritability by 2025. This success aligns with the company’s mission to advance treatments for underserved neurological conditions, with future readouts expected in Alzheimer’s disease and bipolar disorder in the coming years.

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