The US Food and Drug Administration (FDA) announced on Thursday that it has approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults.
This approval was granted to US pharmaceutical company Bristol-Myers Squibb (NYSE:BMY).
Cobenfy is the first antipsychotic drug approved to treat schizophrenia that targets cholinergic receptors, as opposed to dopamine receptors. Its effectiveness for the treatment of schizophrenia in adults was assessed in two randomised, double-blind, placebo-controlled, multi-centre studies in adults with a diagnosis of schizophrenia based on DSM-5 criteria.
Tiffany Farchione, MD., director of the Division of Psychiatry, Office of Neuroscience in the FDA's Center for Drug Evaluation and Research, 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. 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."
LEO Pharma reports positive phase 2b results for temtokibart in atopic dermatitis
New England Biolabs achieves B Corporation recertification
Palatin presents symptom resolution data from Phase 3 dry eye disease trial
BioArctic expands exidavnemab trial to include Multiple System Atrophy patients
NeuroSense Therapeutics completes PrimeC commercial manufacturing scale-up
SCG releases SCG101 late-breaking clinical data in HBV-related hepatocellular carcinoma
Genprex signs new research agreement with University of Pittsburgh to advance diabetes gene therapy
AstraZeneca and Daiichi Sankyo's Enhertu shows strong results in early-stage breast cancer trial