After long journey, Karuna's schizophrenia drug gets FDA decision date

Karuna Therapeutics officially has its date with the FDA. The agency will decide on the approval of KarXT for schizophrenia by Sept. 26, 2024.

The FDA has accepted the Boston biotech’s new drug application for KarXT, a combination of xanomeline-trospium, for adult patients with schizophrenia, according to a Wednesday press release.

If approved, Karuna would be able to offer one of the first new therapies for schizophrenia in years, but most importantly, KarXT would represent a brand new class of drugs for physicians to offer patients.

“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,” said CEO Bill Meury, who was brought on earlier this year as it transitions to a commercial biotech.

The application for KarXT was submitted fully at the end of September. At the time, Karuna anticipated a launch in the second half of 2024. Assuming the therapy is approved on time, Karuna still expects to keep to that timeline, a spokesperson confirmed to Fierce Biotech. 

Mizuho Securities analysts have forecast massive potential for KarXT, with peak global sales estimated at $6.2 billion. 

KarXT is a dual M1/M4 muscarinic agonist that targets a region of the central nervous system that is thought to control the positive, negative and cognitive symptoms of schizophrenia. The therapy is more targeted and does not block dopamine receptors like existing treatments, which means it could offer an option with fewer side effects than traditional antipsychotic treatments.

Karuna Chief Operating Officer Andrew Miller, Ph.D., recalled the long journey to get KarXT from Eli Lilly’s discard pile to the FDA’s office in an interview with Fierce in October. He hoped the biotech’s success would inspire investors and other companies to take on mental health disorders such as schizophrenia.

“From a biopharmaceutical industry perspective, people follow success. Investors follow success. Companies follow success—and, in schizophrenia, we haven't had the opportunity to launch a new class of product,” Miller said.