Celltrion Healthcare has just announced positive progress for extending the authorization for the subcutaneous (SC) form of Remsima to five more autoimmune conditions. These are-
The Committee for Medicinal Products for Human Use of the EMA has officially recommended that Remsima be extended to these conditions, which is a huge step. Marketing authorization for Remsima in the EU was provided back in 2019 for Rheumatoid Arthritis (RA). The hope is that the EMA will approve Remsima’s SC use for these new indications soon.
Currently, Remsima is administered using IV. A SC formulation takes a shorter time than the IV form to administer and it can be administered by the patient themselves. In the time of a global pandemic, this is huge. It means patients don’t have to take regular trips to a hospital to receive their IV therapy. This form would give them more control of their own treatment. Additionally, it offers flexibility.
The positive recommendation from this committee came from a 1 year study investigating the safety, pharmacokinetics, and efficacy of the therapy in ulcerative colitis and Crohn’s disease patients.
Part 1 of the study found that there was a comparable clinical response for the SC and the IV groups of Crohn’s disease patients. Safety profiles were the same and clinical remission was actually higher for the SC group.
Part 2 of the investigation included 131 patients who were randomized to receive the SC form at 120mg or at 240mg every two weeks. The other group received 5mg of the IV treatment every 8 weeks. After 30 weeks, all of the IV patients were changed to a SC administration and dosed depending on their body weight.
Disease activity was decreased in ulcerative colitis patients for the SC groups. After the IV group was switched, they also had similar improvements. The clinical response as well as rates of remission were still maintained at week 54. Further, mucosal healing continued to improve until week 54. The safety profile of the SC and IV groups were comparable.
Based on the results of both part 1 and part 2 of the trial, a 120mg dose of the SC treatment has been recommended. This dose is not recommended to be altered based on body weight.
This therapy has been used in 90 different countries over the past five years. If it is approved for these newer indications, it will be the very first infliximab with both an IV and SC formulation for these patients.
You can read more about this study here.