EU Joins United States in Approving Sarilumab to Treat Rheumatoid Arthritis

The European Commission this week granted marketing authorization for sarilumab (Kevzara) in combination with methotrexate (MTX) to treat adults with moderate-to-severe active rheumatoid arthritis (RA) who had an inadequate response to 1 or more disease-modifying anti-rheumatic drugs (DMARDs).

Sarilumab is a humanized monoclonal antibody designed to bind to the interleukin-6 receptor (IL-6R), blocking IL-6 mediated signaling, according to a Sanofi press release.

“RA is a difficult-to-treat, lifelong disease and many health care providers are challenged with finding a treatment that works for their patients,” Elias Zerhouni, MD, president of Global R&D at Sanofi, said in a release. “Kevzara works differently than some of the other most commonly used biologics, and its approval is good news for the many patients with a high unmet need.”

This chronic disease affects an estimated 1.3 million Americans and approximately 2.9 million Europeans. Globally, as much as 1% of individuals are living with RA.

“We are pleased to bring Kevzara to European patients who may not be respond to the most commonly used biologics such as TNF inhibitors, or who may be seeking an effective monotherapy to reach their treatment goals,” George D. Yancopoulos, MD, PhD, founding scientist, president, and chief scientific officer at Regeneron, said in a release. “This approval was made possible through the hard work of our innovative scientists, as well as thousands of dedicated investigators and patients around the world who participated in the SARIL-RA clinical trial program.”

The approval is based on the positive opinion by the Committee for Medicinal Products for Human Use (CHMP), which examined the results from seven phase 3 trials in the global SARIL-RA clinical development program.

SARIL-RA includes the phase 3 MONARCH study, which found that 200 mg of sarilumab monotherapy was superior to 40 mg of adalimumab (Humira) monotherapy in reducing disease activity and improving physical function—–with more patents who achieved clinical remission over 24 weeks.

Findings from the phase 3 MOBILITY were also included, according to the release. Patients treated with sarilumab plus MTX experienced a reduction in signs and symptoms, and improvement in physical function. Furthermore, the progression of structural damage was inhibited by 91% in patients administered 200 mg of sarilumab and 68% for those administered 150 mg of sarilumab.

Sarilumab was granted FDA approval in May 2017, marking the 11th biologic approval to date for the treatment of RA. Sarilumab is also approved in Canada.