BRIEF—ICER to assess Karuna's treatment for schizophrenia

The USA’s Institute for Clinical and Economic Review ( ICER) announced today that it will assess the comparative clinical effectiveness and value of xanomeline tartrate/trospium chloride, known as KarXT, from Karuna Therapeutics, for the treatment of schizophrenia.

The assessment will be publicly discussed during a meeting of the New England CEPAC ( New England CEPAC) in February 2024, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.

Karuna says that it is on track to submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) in mid-2023, with a potential launch in the second half of 2024.