Celltrion’s Zymfentra (Infliximab-Dyyb) Receives the US FDA’s Approval for the Treatment of Inflammatory Bowel Disease
Shots:
- The approval was based on the P-III clinical trials (LIBERTY-UC) & (LIBERTY-CD) evaluating the safety & efficacy of Zymfentra vs PBO as maintenance therapy in patients (n=438 & 343) with UC & CD following treatment with an infliximab
- The results from both studies depicted a greater clinical remission at 54wks. with Zymfentra (43.2% & 62.3%) vs PBO (20.8% & 32.1%) whereas the endoscopic response rate evaluated in the (LIBERTY-CD) trial was also seen to be greater in Zymfentra (51.1%) vs PBO (17.9%). The safety for both studies was similar to PBO during the maintenance period
- Zymfentra is a subcutaneous version of Celltrion’s infliximab biosimilar which blocks the action of TNF-alpha
Ref: Biospace | Image: Celltrion
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