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FDA accepts resubmission of BLA for Kevzara in treatment of RA

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The FDA has accepted the resubmission of the biologics license application for Kevzara, by Regeneron Pharmaceuticals Inc. and Sanofi, for rheumatoid arthritis as a Class 1 response with a 2-month review, according to a company press release.

According to the Prescription Drug User Fee Act, the new target date is May 22. Kevzara (sarilumab) — a human monoclonal antibody targeted against the interleukin-6 receptor — will be assessed for the treatment of adults with moderate to severe rheumatoid arthritis who had an inadequate response to a disease-modifying antirheumatic drug.

Recently, the European Medicine Agency’s Committee for Medicinal Products for Human Use granted a positive opinion for sarilumab and the European Commission is expected to make its decision on the marketing authorization application in the “coming months.”

Reference :

investor.regeneron.com/releasedetail.cfm?releaseid=1023450