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European Commission approves Kevzara for RA

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The European Commission has granted marketing authorization for Kevzara as combination therapy with methotrexate for patients with moderately to severely active rheumatoid arthritis and who have failed or are intolerant to disease-modifying antirheumatic drugs, according to a company press release.

Kevzara (sarilumab; Sanofi and Regeneron Pharmaceuticals Inc.) has also been approved as monotherapy if the patient is intolerant to methotrexate or if methotrexate use is inappropriate.

“[Rheumatoid arthritis] 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 the release. “Kevzara works differently from some of the other most commonly used biologics, and its approval is good news for the many patients where a high unmet need remains.”

Elias Zerhouni

The interleukin-6 inhibitor had a clinical development program of 3,300 adults with RA. The recommended dose is a subcutaneous injection of 200 mg once every 2 weeks. In cases of lab abnormalities, the dose can be reduced to 150 mg once every 2 weeks. The most frequent adverse events were neutropenia, increased alanine aminotransferase, injection site erythema, upper respiratory infections and urinary tract infections.

In May, the FDA approved Kevzara in the United States.

George D. Yancopoulos

“We are pleased to bring Kevzara to European patients who may not be responding to the most commonly used biologics, such as [tumor necrosis factor] TNF inhibitors, or who may be seeking an effective monotherapy to reach their treatment goals,” George D. Yancopoulos, MD, PhD, president and chief scientific officer of Regeneron, said in the 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.” – by Will A. Offit

Reference:

newsroom.regeneron.com/releases.cfm