Karuna submits KarXT, a novel schizophrenia drug, to FDA for approval

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Karuna Pharmaceuticals has taken a significant step towards gaining approval for its schizophrenia drug, KarXT, as it formally submitted its new drug application to US regulators. The company had previously projected a submission in the third quarter, with a potential launch slated for the second half of 2024 if approved. The submission is supported by data from three placebo-controlled studies, comprising two phase 3 trials and one phase 2 trial, in addition to two ongoing long-term extension trials.

Karuna achieved positive results in all three completed trials, with the first phase 3 trial’s results in August 2022 indicating a nearly 10-point reduction on the Positive and Negative Syndrome Scale for Schizophrenia, a key measure of symptom severity. The second phase 3 trial, concluded earlier this year, demonstrated an 8.4-point reduction on the same scale compared to placebo at week 5.

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One of Karuna’s key selling points has been its drug’s clinical performance, coupled with its ability to avoid the side effects that often plague existing schizophrenia treatments, such as drowsiness and weight gain. 

“KarXT, if approved, will represent the first novel pharmacological approach to treating schizophrenia in several decades and provide a new treatment option for patients and their physicians.” 

– Bill Meury, President and CEO

The promising market potential of KarXT recently attracted Royalty Pharma, which invested $100 million in PureTech, the parent company of Karuna, in exchange for a share of future sales. Royalty Pharma stands to receive 3% of the first $2 billion in sales, followed by a third of the proceeds beyond that threshold. PureTech could also earn an additional $400 million in milestone payments.

Karuna is well-positioned for its forthcoming commercial efforts, boasting $1.4 billion in cash reserves as of the end of June. The company is also exploring opportunities to expand KarXT’s applications, including ongoing trials to assess its effectiveness as a treatment for psychosis in Alzheimer’s patients and as an adjunctive therapy alongside another psychosis medication, among other potential uses.

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