Health Canada Grants Approval for Remsima™ SC in Treating Inflammatory Bowel Disease (IBD)

Celltrion Healthcare Canada Limited has announced today that Health Canada has granted approval for Remsima™ SC as maintenance therapy for adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD). Remsima™ SC, a subcutaneous form of infliximab, received approval from Health Canada in 2021 for treating adult patients with rheumatoid arthritis (RA).

The approval was founded on clinical evidence, including findings from the LIBERTY UC and LIBERTY CD studies, demonstrating Remsima™ SC’s efficacy and safety as maintenance therapy for patients with moderately to severely active UC and CD. Throughout the 54-week study period, Remsima™ SC exhibited superiority in achieving primary endpoints of clinical remission (UC and CD) and endoscopic response (CD) compared to placebo as maintenance therapy following induction therapy of intravenous infliximab in UC and CD patients. The safety profile of Remsima™ SC during the maintenance period was similar to that of placebo in both studies, with no new safety signals observed.

Professor Peter Lakatos, MD PhD DsC FEBG AGAF, from the Department of Medicine at McGill University, expressed, “Canada has one of the highest rates of IBD in the world, and these diseases place a burden on individuals, caregivers, and our healthcare system. There is still an unmet need for new treatment options or modalities for patients living with moderate to severe UC and CD. Remsima™ SC now offers this new option for physicians and patients in this space. We are excited about the potential of Remsima™ SC.”

Jungyong Shin, Managing Director at Celltrion Healthcare Canada, commented, “The availability of an infliximab treatment option from Celltrion healthcare Canada, now in a subcutaneous delivery, is an advancement for the patients and healthcare providers in Canada. Patients now have the opportunity to choose how and where they receive infliximab treatment; in an infusion center, at a physician’s office, and now with Remsima™ SC, the option to receive treatment at home – providing more flexibility and freedom of choice. We are pleased that with Remsima™ SC patients now have the option to manage their condition in accordance with their lifestyle and we aim to bridge any gap for the patients’ accessibility.”

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