Canada has become the first country to approve Sanofi and Regeneron’s new rheumatoid arthritis (RA) drug sarilumab after the US FDA turned down the drug last year.
Health Canada has given a green light to the interleukin-6 inhibitor – under the Kevzara brand name – for the treatment of moderately to severely active RA in adults who have had an inadequate response or intolerance to one or more biologic or non-biologic disease-modifying anti-rheumatic drugs (DMARDs).
Last October, the FDA sent a complete response letter to Sanofi and Regeneron saying it was unable to approve the drug because of deficiencies at a manufacturing facility where sarilumab is filled and finished. Sanofi said it now expects to resubmit an application to the FDA this quarter while a decision from the EU authorities is due later this year.
Sarilumab is a fully human monoclonal antibody that binds specifically to both soluble and membrane-bound IL-6 receptors, and is the first direct competitor to Roche’s Actemra/RoActemra (tocilizumab) the only drug in the class on the market.
First launched in 2010, Actemra has been a big earner for Roche, growing 16% to reach $1.7bn in sales last year, but is expected to face stiff competition from newer drugs in the class thanks to dosing advantages.
Roche’s drug is given either by intravenous injection or subcutaneous injection once a week, while sarilumab is dosed every two weeks. Meanwhile, another IL-6 inhibitor rival – GlaxoSmithKline and Johnson & Johnson’s sirukumab – was filed for approval last year and offers monthly dosing.
“While there have been advances in the treatment of RA, not all available therapies work for every patient and there remains an unmet need for new therapeutic options,” said Sanofi’s David Meeker. “The approval of Kevzara in Canada represents an important advancement in treating adult patients with moderately to severely active RA,” he added, noting that the drug will be launch there “soon”.
The new drug is expected to be a big earner for Sanofi and Regeneron after beating AbbVie’s Humira (adalimumab) – currently the biggest-selling drug in the world – in a comparative trial. Analysts at Credit Suisse have predicted that the drug will bring in more than $500m in 2020, potentially topping $1bn at peak.