Sanofi, Regeneron RA Treatment Superior to Humira in Phase 3 Study

Sanofi and Regeneron Pharmaceuticals said their rheumatoid arthritis treatment sarilumab demonstrated superiority over AbbVie’s blockbuster Humira in a Phase 3 Study.

According to the companies, sarilumab — a human IL-6 receptor antibody — met its primary efficacy endpoint of improving signs and symptoms of RA at week 24.

Adverse event incidence was similar between the groups, each with a rate of 64 percent.

In January, the FDA accepted the BLA for sarilumab for review, setting an Oct. 30 target action date.

Humira has been a huge moneymaker for AbbVie, bringing in more than $14 billion in net revenues last year.

AbbVie spokeswoman Alissa Bolton says the study only evaluated signs and symptoms of RA with monotherapy treatment, while the current standard of care is the combination therapy of anti-tumor necrosis factors and methotrexate, with the goal of preventing the progression of joint damage. This is a clinical measure where Humira has set the standard, she says.