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FDA Approves Therapy for Rheumatoid Arthritis

May 23, 2017

The US Food and Drug Administration (FDA) has approved a therapy for adult patients with active rheumatoid arthritis (RA) and inadequate response to prior treatments.
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RA is a chronic inflammatory autoimmune disease that affects an estimated 1.3 million Americans, most of whom aged 30 to 60 years. Not all patients respond to currently available treatments and some may cycle through different treatments without achieving any treatment goals. Kevzara (sarilumab, Regeneron Pharmaceuticals, Inc) is a human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R) and has been shown to inhibit IL-6R mediated signaling. IL-6 can contribute to inflammation associated with RA.

The FDA approval came following the results of 2 multiple phase III clinical trials involving 2900 adult patients with moderately to severely active RA who had an inadequate response to previous treatment regimens. In the first trial, treatment with Kevzara plus methotrexate reduced signs and symptoms of the disease, improved physical function, and demonstrated significantly less radiographic progression of structural damage compared with placebo plus methotrexate. The second trial reported reduced signs and symptoms of RA as well as improved physical function after Kevzara plus disease modifying antirheumatic drugs, compared with placebo plus disease modifying antirheumatic drugs.

Adverse events associated with Kevzara include neutropenia, increased alanine aminotransferase, injection site erythema, upper respiratory infections, and urinary tract infections

"Today's milestone with Kevzara, which follows closely on the heels of our recent approval of Dupixent (dupilumab), showcases the ability of our internal discovery and science engine to deliver important new medicines by leveraging our leading technologies, such as VelocImmune," said George D Yancopoulos, MD, PhD, Founding Scientist, President, Chief Scientific Officer, Regeneron, in a press release (May 22, 2017).

Kevzara may be administered as a single agent or in combination with methotrexate or other conventional disease modifying antirheumatic drugs. The recommended dosage (200 mg once, every 2 weeks) is to be self-administered as a subcutaneous injection.—Zachary Bessette

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