According to the company, treating rheumatoid arthritis at this critical early phase might prevent irreversible damage to joints and long-term disability.
RoACTEMRA is the first interleukin-6 (IL-6) receptor antagonist to be approved for use in Europe to treat patients with early RA.
Roche Global Product Development head and chief medical officer Dr Sandra Horning said RoACTEMRA is an effective biologic treatment for patients with early RA that may change the course of disease and reduce the likelihood of disability.
"As the first IL-6 receptor antagonist approved for early RA, RoACTEMRA addresses the need for alternative treatment options to anti-tumor-necrosis-factor (anti-TNF) therapies in this debilitating condition," Horning said.
The European approval of RoACTEMRA was based on the Phase III FUNCTION trial, which evaluated the efficacy, safety and prevention of structural joint damage in patients with early moderate-to-severe RA not previously treated with MTX.
The trial met its primary endpoint, showing that patients who received RoACTEMRA in combination with MTX or as a single agent therapy experienced a significantly improvement in disease activity after 24 weeks compared to patients who received MTX alone.