Sanofi is celebrating new data from a comparative trial which showed its rheumatoid arthritis (RA) candidate sarilumab was more effective than AbbVie’s market-leading Humira.
Top-line results from the trial revealed that sarilumab – an interleukin-6 inhibitor – was more effective than TNF inhibitor Humira (adalimumab) in improving the signs and symptoms of patients with active RA after 24 weeks’ treatment.
Sarilumab is being developed by Sanofi and Regeneron, who have predicted that the drug could be a blockbuster with sales in excess of $1bn a year.
The two companies filed for approval of the drug in the US earlier this year on the basis of placebo-controlled trials showing the antibody was effective for patients with active, moderate-to-severe RA who had an inadequate response to previous treatment regimens.
Data from the new SARIL-RA-MONARCH study – which was conducted in 369 patients who had not responded to or could not tolerate methotrexate – may be added to sarilumab’s US label at a later date. The drug is also scheduled for filing in the EU in the second half of 2016.
Patients on sarilumab experienced a significantly greater improvement on a composite measure of efficacy used in the study (DAS28-ESR), which covers symptoms of the disease, general health levels and laboratory markets of inflammatory disease.
Janet van Adelsberg, senior director for clinical sciences, immunology and inflammation at Regeneron, said: “This is the first time an IL-6 receptor blocker delivered subcutaneously has demonstrated superiority over adalimumab monotherapy in RA.”
One drug in the class is already on the market – Roche’s Actemra/RoActemra (tocilizumab) – which has been enjoying buoyant growth and brought in CHF 1.4bn ($1.4bn) in sales last year, a rise of 25%. The drug was originally delivered as an infusion but latterly has been made available in a subcutaneous formulation.
Other companies developing IL-6 inhibitors for RA include GlaxoSmithKline (GSK) and Janssen, whose sirukumab candidate is scheduled for filing later this year, and Alder Bio Pharmaceuticals which has clazakizumab in phase II. UCB had been developing its own candidate called olokizumab in phase II, but licensed it to Russia’s R-Pharm in 2013.
Simon Cooper, global project head, immunology and inflammation at Sanofi, said: “Despite the availability of a wide range of treatment options, we believe that new therapies are needed to further address unmet needs of RA patients.
“These data suggest that sarilumab, if approved, may be an option for patients unable to tolerate or take methotrexate, and we look forward to sharing further details at an upcoming medical congress.”