U.S. FDA greenlights Kevzara for rheumatoid arthritis.

Sanofi and Regeneron announced this Monday, that Kevzara (sarilumab), their jointly produced treatment, has been approved for adult patients in the U.S. According to Sanofi/Regeneron, Kevzara is a human Mab that binds to the interleukin-6 IL-6R) receptor and has been shown to inhibit IL-6R mediated signaling. Over time, IL-6 cytokine builds up in the human body — Kevzara limits the crippling and chronically damaging inflammatory response to this build up.

Designed for patients who have had inadequate response to drugs like Methotrexate, Kevzara demonstrated improvement in adult patients. Alan Kivitz, Founder and Medical Director of the Altoona Center for Clinical Research and Altoona Arthritis and Osteoporosis Center, as well as investigator for the global SARIL-RA (sarilumab) clinical program, said "In the clinical trial program, sarilumab demonstrated statistically significant, clinically-meaningful improvements in adult patients with rheumatoid arthritis by reducing signs and symptoms, improving physical function, and resulting in significantly less radiographic progression of structural damage of RA.”

According to the two companies, Kevzara’s US Wholesale Acquisition Cost is $39,000 annually for the drug’s 200 mg and 150 mg doses, a price approximately 30% lower than the WAC for the next two most widely used TNF-alpha inhibitors. “Actual costs to patients, payers and health systems,” said the announcement, “are anticipated to be lower as WAC does not reflect discounts, rebates or copay support."