Wednesday, 13 Dec 2017

You are here

IL-6 Inhibitor Kevzara Granted FDA Approval for Rheumatoid Arthritis

The FDA has approved sarilumab (Kevzara), a new IL-6 inhibitor co-developed by Regeneron and Sanofi's, for use in adults with moderate to severe rheumatoid arthritis (RA).

Although approved in Canada in February 2017, the US submission of the sarilumabs BLA was held up by the FDA with a complete response letter and concerns about manufacturing.

Kevzara is indicated for adult patients with moderate to severe, active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to at least one DMARD. It is and anti-IL-6 receptor targeted therapy.

Sarilumab is off to a unique start with the manufacturers pricing the product 30% lower than TNF inhibitor competitors, and will carry a list price of $39,000 per year for the 200 milligram and 150 mg doses.

FDA approval is based on approximately 2,900 RA patients where it has been shown to yield significant clinical improvement and significantly less radiographic progression compared to placebo plus MTX.

The safety profile of sarilumab appears to be similar to other IL-6 inhibitors studied in RA.

The package insert (http://buff.ly/2rPpTFc) states that the drug is indicated for use as monotherapy or in combination with methotrexate (MTX) or other conventional DMARDs, at a dose of 200 mg once given subcutaneously every two weeks,  It comes with warnings about serious infection, bowel perforations, neutropenia, transaminitis and hyperlipidemia. It requires TB screening prior to use and should not be given with live virus vaccines. 

Disclosures: 
The author has no conflicts of interest to disclose related to this subject

Add new comment

More Like This

Kidney Dysfunction Frequent in RA

Renal dysfunction is common among patients with rheumatoid arthritis (RA), particularly among older patients, women, and those with hypertension, Japanese researchers reported.

Using absolute estimated glomerular filtration rates (eGFR), 33.8% of patients had renal dysfunction, according to Shunsuke Mori, MD, of Kumamoto Saishunsou National Hospital in Kohshi, and colleagues. 

Offspring of RA Women Have Higher Risk of RA and Other Diseases

Despite a growing body of evidence suggesting that maternal health is more important than maternal medications to fetal and infant outcomes, little is known about the long term oucomes of infants born to mothers with rheumatoid arthritis (RA). Using Danish population data, researchers have shown in utero exposure to maternal RA is associated with an increased risk of thyroid disease, and an increased risk of future RA.

CDC Lyme Disease Surveillance Report

Lyme disease, caused by the spirochete Borrelia burdofgeri, is the most common vector-borne illness reported in the U.S. Cases occur mainly in the Northeast, Mid-Atlantic and upper Midwest as well as certain areas of the Pacific coast, with a geographic distribution based on residence of Ixodes scapularis (Ixodes pacificus on the West Coast), the vectors that transmits Lyme disease.

Vitamin D Insensitivity in the Rheumatoid Joint

Researchers from the University of Birmingham have shown that while Vitamin D may be effective at preventing the onset of inflammation, it is less effective once inflammatory disease is established - largely because, once established, rheumatoid arthritis leads to vitamin D insensitivity. (Citation source https://buff.ly/2iGHYmI)

Stroke Increased in Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a chronic, inflammatory disease with systemic effects beyond the joints. While RA patients are known to have signficantly higher risks for cardiovascular disease and venous thromboembolic events, an association with stroke (CVA) is unclear.

A study claims data from Israel analyzed 11,782 RA patients and 57,973 age- and gender-matched controls.