Sanofi and partner Regeneron remain on course to file for approval of their rheumatoid arthritis drug sarilumab before the end of the year after reporting positive phase III data.
The interleukin-6 (IL-6) targeting antibody has been shown to be effective in another late-stage trial – SARIL-RA-TARGET – improving symptoms of RA significantly better than placebo in patients who did not respond to or couldn’t tolerate TNF inhibitors such as AbbVie’s Humira (adalimumab) and Amgen’s Enbrel (etanercept).
After 12 weeks’ treatment on top of non-biologic disease modifying anti-rheumatic drugs (DMARD) therapy, sarilumab given every two weeks by subcutaneous injection achieved a 20% improvement in symptoms in 56% of a low-dose (150mg) group and 61% of a high-dose (200mg) group. In contrast, just 31% of placebo-treated patients achieved that level of benefit.
TARGET is just the latest in a battery of phase III trials exploring the potential of sarilumab in RA, and adds to the view that the drug could represent a step change in biologic treatment for the disease. The data reinforces the results of the MOBILITY trial reported in 2013 and also the EASY trial looking at an auto-injector for the drug.
The drug works in a similar fashion to Roche’s Actemra/RoActemra (tocilizumab) but differs in that it is a fully human rather than a humanised antibody. Whether that difference translates to any clinical advantage remains to be seen, but the latest data reinforce the role of IL-6 inhibition in RA.
Actemra has been gaining momentum in RA therapy, with sales rising 23% last year to reach more than 1.2bn Swiss francs ($1.29bn) thanks to the continued uptake of a new subcutaneous formulation which has replaced an earlier 60-minute infusion, as well as increased use as a monotherapy in place of TNF blockers.
Regeneron chief scientific officer George Yancopolous said earlier this year that sarilumab could provide “an important new treatment option to the RA community, where patients often cycle through multiple medicines during the course of their disease.”
Analysts have suggested sarilumab could also make significant headway in RA treatment, potentially bringing in more than $1bn at peak.