Posted by Michael Wonder on 28 Jul 2020
European Commission grants marketing authorisation for world’s first subcutaneous formulation of infliximab, Remsima SC, for an additional five indications including for use in inflammatory bowel disease and ankylosing spondylitis
27July 2020 - The EU marketing authorisation is based on pivotal data comparing the pharmacokinetics, efficacy and safety of the intravenous and subcutaneous formulations of Remsima in people with active Crohn's disease and Ulcerative colitis.
Celltrion Healthcare today announced that the European Commission has granted marketing authorisation for Remsima (infliximab, CT-P13) subcutaneous formulation for the treatment of adult patients with ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis.
The approval follows a positive opinion issued by the CHMP of the EMA in June and is based on data from a pivotal study comparing the pharmacokinetics, efficacy and safety of the subcutaneous and intravenous formulations of Remsima in people with active Crohn’s disease and ulcerative colitis, throughout a 1-year treatment period. Based on the results of the pivotal study, a 120 mg fixed dose of Remsima SC has been approved for use in the European Union, in adults regardless of body weight, in both existing and newly added indications.
