Karuna's schizophrenia drug NDA accepted by FDA

Boston, USA-based biopharma Karuna Therapeutics has announced the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for KarXT (xanomeline-trospium) to treat schizophrenia in adults.

The application has been granted a Prescription Drug User Fee Act (PDUFA) date of September 26, 2024.

"KarXT could be one of the more important new product introductions in neuropsychiatry by providing a novel pharmacological approach"If approved, KarXT would represent the first new pharmacological approach to treating schizophrenia in several decades.