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Celltrion’s Zymfentra (Infliximab-Dyyb) Receives the US FDA’s Approval for the Treatment of Inflammatory Bowel Disease

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Celltrion’s Zymfentra (Infliximab-Dyyb) Receives the US FDA’s Approval for the Treatment of Inflammatory Bowel Disease

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  • 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

Related News:- Sanofi Collaborated with Teva to Co-Develop and Co-Commercialize TEV ‘574 for Inflammatory Bowel Disease

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Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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