Karuna Therapeutics Gets FDA Acceptance for KarXT NDA
29 Novembro 2023 - 9:13AM
Dow Jones News
By Chris Wack
Karuna Therapeutics said the U.S. Food and Drug Administration
has accepted its New Drug Application for KarXT xanomeline-trospium
for the treatment of schizophrenia in adults.
The application has been granted a Prescription Drug User Fee
Act date of Sept. 26, 2024.
The NDA submission is supported by long-term safety data from
the clinical program evaluating KarXT as a treatment for
schizophrenia. The program includes the three completed positive
trials evaluating the efficacy and safety of KarXT compared with
placebo, and trials evaluating the long-term safety of KarXT.
In all three placebo-controlled trials, KarXT met its primary
endpoint, demonstrating statistically significant and clinically
meaningful improvements in symptoms of schizophrenia compared with
placebo. KarXT was found to be generally well tolerated, with the
most common adverse events being cholinergic in nature and mild to
moderate in severity.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
November 29, 2023 06:58 ET (11:58 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
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