Celltrion Wins US FDA Nod for RA Trial of Zymfentra
MT Newswires Live
Sep 23
Celltrion (KRX:068270) received U.S. Food and Drug Administration approval to launch a Phase 3 clinical trial in the U.S. for Zymfentra (CT-P13 SC), a subcutaneous version of its infliximab biosimilar, in patients with rheumatoid arthritis.
The study will enroll 296 patients over 52 weeks and aims to demonstrate superiority to placebo in reducing disease symptoms by Week 12. Zymfentra is already approved in several countries for ulcerative colitis and Crohn's disease, and the new trial could extend its use to rheumatoid arthritis.
Celltrion said the US FDA does not issue separate approval notices for new Phase 3 trials, with confirmation deemed effective 60 days after submission.
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.