On 30 October 2024, Celltrion announced results of a global phase 3, 2-year follow-up study comparing infliximab SC (CT-P13, Zymfentra™) as monotherapy and in combination with immunosuppressants. Celltrion reports that the study found Zymfentra™ as monotherapy was just as effective and safe as when combined with immunosuppressants for patients with Crohn’s disease or ulcerative colitis, suggesting “monotherapy can be a sufficiently safe and effective treatment option”. The results were presented at the 2024 American College of Gastroenterology conference (25-30 October 2024).
This news follows Celltrion’s 19 August 2024 announcement that the FDA has approved a phase 3 clinical trial of Zymfentra™ for rheumatoid arthritis.
Zymfentra™ was the first subcutaneous formulation of infliximab approved by the FDA for ulcerative colitis and Crohn’s disease in October 2023. It was launched in the US in March 2024.
In Europe, Zymfentra™ is known as Remsima SC® and has been approved since 2013.