Paris (France) and Tarrytown (New York), 27 June 2017 – Sanofi and Regeneron Pharmaceuticals, Inc. announced today that the european Commission (EC) issued a marketing authorisation on the market to Kevzara® (sarilumab), in combination with methotrexate (MTX) in the treatment of active rheumatoid arthritis, moderate to severe, the adult who has submitted an inadequate response or intolerance to one or more treatments for ra of the bottom, such as methotrexate (MTX). Kevzara can be given as monotherapy in case of intolerance or contraindication to methotrexate.1
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Kevzara is a human monoclonal antibody that binds to the receptors of the interleukin-6 (IL-6R) and inhibits signal transmission mediated by these receptors. The presence of elevated concentrations of interleukin-6 (IL-6) in the synovial fluid of joints of patients with rheumatoid arthritis plays an important role in inflammation pathology and the joint destruction characteristic of this disease.1
“Rheumatoid arthritis is a chronic disease difficult to treat and many health professionals are struggling to find a treatment that works on their patients,” said dr. Elias Zerhouni, President, global R&D, Sanofi. “Kevzara has a different mechanism of action of some of the biological agents most frequently used and its approval is great news for many patients with significant unmet needs. ”
Rheumatoid arthritis affects approximately 2.9 million people in Europe. It is characterized by a dysregulation of the immune system that causes it to attack tissues of the joints, causing an inflammatory condition, pain, edema, stiffness, fatigue, and joint damage and functional disabilities., It most often manifests between the ages of 35 and 50 years.
“We are very happy to put Kevzara available to the european patients who do not respond to the biological agents most frequently prescribed, such as the TNF inhibitor, or who are looking for a monotherapy to be effective in achieving their treatment goals,” said Dr. George D. Yancopoulos, Ph.D., Researcher-Founder, President, and Chief Scientific officer of Regeneron. “We need this approval to the work of innovative and hard-working of our researchers, as well as to the commitment of thousands of investigators and patients in the world who have participated in the clinical trial program PAMUK-RA. ”
The approval of the european Commission following the favourable opinion delivered by the Committee for medicinal products for human use (CHMP, Committee for Medicinal Products for Human Use) of the european medicines Agency (EMA) following the evaluation of the results of seven phase 3 trials from the clinical development program overall PAMUK-RA. These studies provide data on over 3,300 adult patients with active rheumatoid arthritis, moderate to severe, have submitted an inadequate response or intolerance to one or more treatments for ra of the bottom, biological or not.1
This program includes the phase 3 MONARCH in which monotherapy Kevzara 200 mg was superior to monotherapy with adalimumab 40 mg (marketed by AbbVie under the brand name HUMIRA®) and has helped to reduce disease activity, improve physical function and to obtain a clinical remission after 24 weeks among a larger number of patients.1
After 24 weeks, the decrease of the activity of the disease, as measured by the change in the score of disease activity at the level of 28 joints and the erythrocyte sedimentation rate (DAS28-ESR), compared to the score at baseline (the primary endpoint of the study), was higher in patients treated with Kevzara (Kevzara, -3,28 ; adalimumab, -2,20).
After 24 weeks, the improvements in physical function measured through the questionnaire, HAQ-DI (Health Assessment Questionnaire – Disability Index) were higher in patients treated with Kevzara (secondary endpoint). The change compared to the score, the HAQ-DI in the beginning is established to -0,61 for Kevzara, against
-0,43 for adalimumab.
After 24 weeks, the remission rates measured by the score DAS28-VS (score