ARTICLE | Company News
FDA again reviewing Kevzara
April 28, 2017 9:20 PM UTC
Sanofi (Euronext:SAN; NYSE:SNY) and partner Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said FDA accepted a resubmitted BLA for Kevzara sarilumab to treat moderately to severely active rheumatoid arthritis. Its PDUFA date is May 22.
In October 2016, the partners said FDA issued a complete response letter for Kevzara, citing deficiencies in Sanofi's French manufacturing facility, and said they had submitted a corrective plan to the agency. In February, Health Canada approved the mAb against IL-6 receptor, its first approval in the world (see BioCentury Extra, Feb. 1). ...
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