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FDA Approves Kevzara to Treat Moderate to Severe Rheumatoid Arthritis

May 26, 2017
The agent is indicated for RA patients who have had an inadequate response or intolerance to disease modifying antirheumatic drugs (DMARDs)

The Food and Drug Administration (FDA) has approval of Kevzara (sarilumab) for the treatment of adults with moderate to severe rheumatoid arthritis (RA) “who have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX),” according to a press release from the company.

Kevzara, which is being co-developed by Sanofi and Regneron Pharmaceuticals, Inc, is a human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R). "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," said Alan Kivitz, MD, CPI, Founder and Medical Director of the Altoona Center for Clinical Research and Altoona Arthritis and Osteoporosis Center, and an investigator in the global SARIL-RA clinical program for sarilumab.

According to a press release, Kevzara may be used as monotherapy or in combination with MTX or other conventional DMARDs. The recommended dosage of Kevzara is 200 mg once every 2 weeks given as a subcutaneous injection, which can be self-administered. The dosage can be reduced from 200 mg to 150 mg once every 2 weeks, as needed, to help manage side effects, including neutropenia, thrombocytopenia, and liver enzyme elevations.

The approval of Kevzara was based on studies including over 2,900 adults with moderately to severely active RA who had an inadequate response to previous treatment regimens. In 2 Phase 3 clinical trials, Kevzara plus DMARDs demonstrated “statistically significant, clinically-meaningful improvements in patients with moderately to severely active RA,” noted the company.

Patients treated with Kevzara are at increased risk of developing serious infections that may lead to hospitalization or death. The most common adverse reactions (occurring in at least 3% of patients treated with Kevzara in combination with DMARDs vs. placebo in combination with DMARDs) observed with Kevzara in the clinical studies were neutropenia (7-10% vs. 0.2%), increased alanine aminotransferase (5% vs. 2%), injection site erythema (4%-5% vs. 0.9%), upper respiratory infections (3%-4% vs. 2%) and urinary tract infections (3% vs. 2%).

For more information, please call 1-844-Kevzara (1-844-538-9272) or visit www.Kevzara.com.

Last updated on: November 5, 2020
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