(Health Korea News / Yoo Ji-in) Celltrion officially announced the results of phase 3 clinical trials of ‘CT-P47’, a biosimilar to ACTEMRA (ingredient name: tocilizumab) for the treatment of rheumatoid arthritis (RA), through the European Rheumatology Association (EULAR). It was announced on the 21st that it was published in the journal ‘Rheumatic&Musculoskeletal Disease (RMD Open)’.
Previously, Celltrion compared the efficacy, pharmacodynamics, pharmacokinetics, and safety between CT-P47 and the original drug in the global phase 3 clinical trial of CT-P47. This study is the results of up to week 32 of the Phase 3 clinical trial of the intravenous formulation of CT-P47, which was conducted for 52 weeks on 471 patients with rheumatoid arthritis.
First, the patients were divided into two groups, the CT-P47 administration group and the original drug administration group, and the change in ‘DAS28 (Rheumatoid Arthritis Disease Activity Assessment Tool)’ value compared to the baseline, a major indicator of RA activity, was measured as the primary evaluation index. As a result of the measurement, the difference between the original drug and the CT-P47 administration group in the primary efficacy evaluation index met the predefined equivalence standards, confirming effectiveness, equivalence, pharmacokinetics, and safety compared to the original drug.
At week 24, patients who were randomly assigned to the original medication group were again randomly assigned in a 1:1 ratio to a group that switched to CT-P47 or maintained the original medication. A second trial to evaluate efficacy, pharmacokinetics, safety, and immunogenicity among three groups from 24 to 32 weeks: the CT-P47 dosing group, the dosing group that maintained the original drug administration, and the replacement dosing group that switched to CT-P47 after receiving the original drug. Similar results were confirmed in all evaluation indicators.
Actemra, the original drug, is an interleukin inhibitor that reduces inflammation by inhibiting the interleukin (IL)-6 protein, which is involved in causing inflammation in the body. As of last year, it recorded global sales of about 2.63 billion francs (about 4.165 trillion won). did it
Based on the clinical results, Celltrion completed the application for CT-P47 product approval for all Actemra indications (full label) in major global countries such as Korea, the United States, and Europe early this year, accelerating its entry into the global market. there is.
In particular, as Actemra was released in two formulations, subcutaneous injection (SC) and intravenous injection (IV), CT-P47 was also released in two formulations, subcutaneous injection and intravenous injection, so that medical staff can select a prescription considering the patient’s condition and convenience. is preparing.
A Celltrion official said, “CT-P47 was confirmed to be equivalent and similar to the original drug in the results of the global phase 3 clinical trial,” and added, “Based on these clinical results, we are speeding up the application for approval in major overseas countries and developing the previously released TNF-P47.” “Following α (tumor necrosis factor) inhibitors, we will expand our autoimmune disease portfolio with interleukin (IL) inhibitors,” he said.
Meanwhile, Celltrion has recently been obtaining product approvals for its follow-up biosimilar pipeline, including Omriclo (Xolair biosimilar), Stechyma (Stellara biosimilar), and Idenzelt (Eylea biosimilar). .
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