FDA announcements and updates

FDA Approves Bristol Myers Squibb's Cobenfy, First New Schizophrenia Drug in Seven Decades

Sep 26, 2024, 11:57 PM

The U.S. Food and Drug Administration (FDA) has approved Bristol Myers Squibb's new schizophrenia drug, Cobenfy (formerly KarXT), marking the first novel treatment for the disorder in over seven decades. This approval represents a significant advancement in the treatment of schizophrenia, which affects nearly 3 million adults in the U.S. Unlike existing antipsychotic treatments that target dopamine receptors, Cobenfy operates through a different mechanism, acting on M1 and M4 muscarinic acetylcholine receptors. The drug has shown promise in reducing symptoms with fewer side effects compared to traditional therapies. Bristol Myers Squibb's acquisition of Karuna Therapeutics, the original developer of the drug, was a strategic move that is expected to pay off significantly. The company anticipates peak sales of $6 billion per year, with a 30-day supply costing $1,850. The twice-daily pill is expected to see strong uptake by mid-2025, and it notably does not carry a black box warning common to many antipsychotic drugs. The approval has also positively impacted Bristol Myers Squibb's stock, which saw a 5.7% rise in premarket trading.