BioCentury
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). ...

BCIQ Target Profiles

Interleukin-6 (IL-6)