Sanofi and Regeneron Announce First Approval of KevzaraTM (sarilumab) for the Treatment of Moderately to Severely Active Rheumatoid Arthritis in Adult Patients by Health Canada
- Regulatory decisions for Kevzara are anticipated in the United States and European Union later this year -
Paris, France and Tarrytown, N.Y.- February 1, 2017 - Sanofi and Regeneron Pharmaceuticals, Inc. today announced that Health Canada approved KevzaraTM (sarilumab), an interleukin-6 (IL-6) receptor antibody, 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 (DMARDs).
"With Kevzara, we have a promising new therapy in Canada, which has shown clinically-meaningful and statistically significant improvements in adult patients with moderately to severely active rheumatoid arthritis," said Dr. William Bensen, Clinical Professor of Rheumatology, Department of Medicine at McMaster University, Ontario, Canada. "Kevzara represents a welcome new treatment option that works differently from the most commonly used biologics."
Kevzara is a fully human monoclonal antibody that binds specifically to both soluble and membrane-bound IL-6 receptors, and has been shown to inhibit IL-6-mediated signalling through these receptors.1 Local production of IL-6 by synovial and endothelial cells in joints affected in chronic inflammatory disease, such as RA, may play an important role in development of the inflammatory processes.1
"While there have been advances in the treatment of rheumatoid arthritis, not all available therapies work for every patient and there remains an unmet need for new therapeutic options," said David Meeker, M.D., Executive Vice President and Head of Sanofi Genzyme. "The approval of Kevzara in Canada represents an important advancement in treating adult patients with moderately to severely active RA."
RA is a systemic inflammatory disease that can affect multiple joints in the body. In RA, inflammation manifests in the lining of the joints causing pain, swelling, joint damage and can lead to deformity. RA impacts 70 million adults worldwide., In Canada alone, RA affects approximately 300,000 people. RA is most common in people between 40 and 60 years old; however, it can occur in adults at any age.
The Health Canada approval of Kevzara was based on data from approximately 2,900 adults with moderately to severely active RA who had an inadequate response to previous treatment regimens, including seven studies from the global SARIL-RA clinical program. Kevzara demonstrated clinically-meaningful improvements, either as monotherapy or in combination with conventional DMARDs, including methotrexate, in reducing signs and symptoms, improving physical function, and inhibiting radiographic progression of structural damage of RA in approximately 1,743 patients with moderately to severely active RA.,,,,, Kevzara should be used in combination with methotrexate or other traditional DMARDs, or may be given as monotherapy in cases of intolerance or contraindication to methotrexate or DMARDs.1 The recommended dose of Kevzara is 200 mg once every two weeks given as a subcutaneous injection; dosage can be reduced from 200 mg to 150 mg once every two weeks to help manage certain laboratory abnormalities.1
Patients treated with Kevzara are at increased risk for developing serious infections that may lead to hospitalization or death.1 The most frequent adverse reactions (occurring in at least 3% of patients treated with Kevzara in combination with DMARDs) observed with Kevzara in the clinical studies were neutropenia (6-10%), increased alanine aminotransferase (4-5%), injection site erythema (3-4%), and upper respiratory tract infections (3%).1
Kevzara is expected to be available to patients in Canada soon and there will be a patient support program at the time of product availability. The companies are committed to helping patients who are prescribed Kevzara gain access to the medicine and receive the support they may need. In Canada, Kevzara will be marketed by Sanofi Genzyme, the specialty care global business unit of Sanofi. The full Product Monograph in Canada is available here.
Update on U.S. and European Regulatory Submissions
The resubmission of the sarilumab Biologics License Application (BLA) to the United States Food and Drug Administration (FDA) is expected in the first quarter of 2017. This resubmission is subject to successful completion of an inspection by FDA of Sanofi's Le Trait fill and finish facility, with an anticipated action date in the second quarter.
The European Medicines Agency accepted for review the Marketing Authorization Application for sarilumab in July 2016 and a decision is expected later this year.
"Regeneron and Sanofi look forward to resubmitting the U.S. BLA for Kevzara later this quarter and anticipate a new U.S. action date in the second quarter of 2017," said Robert Terifay, Executive Vice President, Commercial, Regeneron. "We are especially grateful for the commitment of the patients and investigators who participated in our SARIL-RA clinical program, and have helped to bring this important new therapy to RA patients."
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL cholesterol and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, atopic dermatitis, asthma, pain, cancer and infectious diseases. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
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 Kevzara (sarilumab) Product Monograph Health Canada. January 2017.
 Gibofsky, A. Overview of Epidemiology, Pathophysiology, and Diagnosis of Rheumatoid Arthritis. Am J Manag Care. 2012 Dec;18(13 Suppl):S295-302.
 United Nations, Department of Economic and Social Affairs, Population Division (2015). World Population Prospects: The 2015 Revision, Key Findings and Advance Tables. Working Paper No. ESA/P/WP.241.
 The Arthritis Society. Rheumatoid Arthritis. Available at: https://arthritis.ca/understand-arthritis/types-of-arthritis/rheumatoid-arthritis. Last Accessed January 2017.
 Genovese, MC. Sarilumab Plus Methotrexate in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate: Results of a Phase III Study. Arthritis Rheumatology. 2015 Jun 67(6):1424-37..
 Fleischmann, R. Sarilumab and Non-Biologic Disease-Modifying Antirheumatic Drugs in Patients With Active RA and Inadequate Response or Intolerance to TNF Inhibitors. Arthritis Rheumatology. 2016 Nov 10.1002/art.39944..
 Sanofi. To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis (SARIL-RA-EASY). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 28 May 2015]. Available from: https://clinicaltrials.gov/ct2/show/NCT02057250 NLM Identifier: NCT02057250.
 Emery P, Rondon J, Garg A, et al. Safety and tolerability of subcutaneous sarilumab compared to intravenous tocilizumab in patients with RA. Arthritis Rheumatol. 2015;67(suppl 10): 971..
 Burmester G, Garg A, van Hoogstraten H, et al. Sarilumab dose reduction to manage laboratory abnormalities in an open-label extension study in RA patients. Arthritis Rheumatol. 2015;67 (suppl 10): 2762..
 Sanofi. To Evaluate the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Rheumatoid Arthritis (RA) (SARIL-RA-ONE). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 28 May 2015].