U.S. FDA Grants Priority Review to Takeda Pharmaceutical's Zasocitinib NDA for Plaque Psoriasis
MT Newswires Live
Yesterday
The U.S. Food and Drug Administration (FDA) accepted Takeda Pharmaceutical's (TYO:4502) new drug application (NDA) for zasocitinib under priority review for adults with moderate‑to‑severe plaque psoriasis, according to a Monday filing with the Japanese bourse.
The application is supported by Phase III LATITUDE PsO 3001 and 3002 trials, which met all primary and ranked secondary endpoints. About 70% of patients achieved clear or nearly clear skin by Week 16, with improvements seen from Week 4 and sustained through Week 52, the filing said.
Shares of Takeda Pharmaceutical added over 1% at market close.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.