US FDA accepts Karuna Therapeutics’ NDA for KarXT to treat Schizophrenia

US FDA accepts Karuna Therapeutics’ NDA for KarXT to treat Schizophrenia

Karuna Therapeutics, Inc, a biopharmaceutical company driven to discover, develop, and deliver transformative medicines for people living with psychiatric and neurological conditions, announced the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for KarXT (xanomeline-trospium) for the treatment of schizophrenia in adults. If approved, KarXT would represent the first new pharmacological approach to treating schizophrenia in several decades. The application has been granted a Prescription Drug User Fee Act (PDUFA) date of September 26, 2024.

“We are pleased the NDA for KarXT has been accepted, and we look forward to working with the FDA during the review process,” said Bill Meury, president and CEO of Karuna Therapeutics.

“There is a significant need for new treatment options for serious mental illness. If approved, KarXT could be one of the more important new product introductions in neuropsychiatry by providing a novel pharmacological approach for the treatment of schizophrenia.”

“Schizophrenia’s disabling symptoms pose significant challenges to navigating crucial aspects of life, including developing relationships, maintaining employment, and securing safe housing,” said Gordon Lavigne, M.Ed., CEO, Schizophrenia & Psychosis Action Alliance.

“Diagnosis marks the beginning of an often long and tiresome search for effective and tolerable treatment options. The nature and magnitude of side effects often play a pivotal role in whether someone continues treatment, which is often crucial to minimize the risk of relapse and realize the life-altering benefits of long-term treatment.

Potential approval of a pharmacologically distinct treatment option would be a welcome innovation for people living with schizophrenia.”