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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.