AdisInsightThe recent first global approval of sarilumab has been reviewed in detail in the First Global Approval report in Adis journal Drugs, based on the development milestones tracked in AdisInsight.
In February 2017, sarilumab (Kevzara™), developed by Sanofi and Regeneron Pharmaceuticals, received its first global approval in Canada 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). Sarilumab is administered every two weeks subcutaneously. It is an interleukin-6 (IL-6) receptor antibody that binds specifically to, and blocks both soluble and membrane-bound IL-6 receptors; IL-6 is a key mediator of inflammation in RA.
The prevalence of rheumatoid arthritis varies by region, but affects up to 1% of the population worldwide, in Canada the disease affects an estimated 300,000 people.1 2 Sarilmumab is one of a small number of approved agents targeting the IL-6 receptor, and will go head-to-head with Roche’s Tocilizumab (Actemra™)3, a globally-established competitor agent.4
David Meeker, M.D., Executive Vice President and Head of Sanofi Genzyme explained:
“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.”
“The approval of Kevzara in Canada represents an important advancement in treating adult patients with moderately to severely active RA.”2
Sarilumab is under regulatory review in Japan, the US, and EU for RA; US and EU decisions are expected later in 2017.2 Sarilumab is also under phase II investigation for juvenile idiopathic arthritis in multinational trials.
Listed in a Serious Warnings and Precautions Box in the product monograph is the risk for developing serious infections in patients treated with sarilumab.5