On January 12, 2017, Health Canada approved sarilumab (Kevzara) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more biologic or non-biologic disease-modifying anti-rheumatic drugs. This is the first approval in any country for sarilumab, which is a human IgG1 that binds to soluble and membrane-bound forms of the interleukin-6 receptor. Marketing applications for sarilumab were submitted to the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Ministry of Health, Labour and Welfare in Japan. The marketing applications for sarilumab are based on results from Phase 3 trials in the SARIL-RA clinical development program, which includes ~ 2,900 adults with moderately to severely active RA who had an inadequate response or intolerance to previous treatment regimens. FDA issued a complete response letter in October 2016; resubmission of the application to FDA is expected in the first quarter of 2017, and an action by FDA is expected in the second quarter of 2017. An opinion regarding the marketing application submitted to EMA is expected in 2017.
The annual number of first approvals for new antibody therapeutics is expected to reach a record in 2017. Sarilumab’s approval is the first of at least 12 first approvals for new antibody therapeutics expected in 2017. The Antibody Society will post reports on the progress of mAb therapeutics during 2017, with an emphasis on first marketing application submissions and approvals in the European Union, United States and Japan. The Society maintains a comprehensive table of approved antibody therapeutics and those in regulatory review in the EU or US. Please log in to access the table, located in the Members Only section.
Not a member? Please join!
Membership is free for students and employees of the Society’s corporate sponsors.