Remsima SC, the first subcutaneous infliximab, now approved in Canada for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease
The approval of Remsima SC underscores Celltrion’s ongoing commitment to deliver innovative medicines for people living with chronic diseases. (Credit: Diana Polekhina on Unsplash)
Celltrion Healthcare Canada Limited, today announced that Health Canada has approved Remsima™ SC for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD). Remsima™ SC is a subcutaneous form of infliximab, and was approved by Health Canada in 2021 for the treatment of adult patients with rheumatoid arthritis (RA).1
The approval was based on clinical evidence, including results from the LIBERTY UC and LIBERTY CD studies that showed the efficacy and safety of Remsima™ SC as maintenance therapy in patients with moderately to severely active UC and CD. Based on the results of the LIBERTY studies, over a 54-week study period Remsima™ SC demonstrated superiority in the results of the primary endpoints of clinical remission (UC and CD) and endoscopic response (CD) compared to placebo as maintenance therapy after induction therapy of intravenous formulation of infliximab in patients with UC and CD. The overall safety profile of Remsima™ SC was similar to that of placebo during maintenance period in both studies with no new safety signals seen.2,3
“Canada has one of the highest rates of IBD in the world, and these diseases place a burden on individuals, caregivers, and on our healthcare system. There is still an unmet need for new treatment options or modality 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,” said Pr. Peter Lakatos, MD PhD DsC FEBG AGAF, Professor at the Department of Medicine, McGill University, McGill University Health Centre, Montreal General Hospital, Montreal, QC.
“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,” said Jungyong Shin, Managing Director at Celltrion Healthcare 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.”
Source: Company Press Release