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Ethics Of Kevzara's 52-Week Placebo Trial Weighed On US FDA

Although lengthy duration of placebo treatment was not flagged for concern in first-cycle review of Sanofi/Regeneron's sarilumab for rheumatoid arthritis, it drew considerable attention in the BLA's second go-around at FDA, which included an ethics consult and a center director briefing.

Film x-ray knee joint with arthritis

Sometimes, the longer the US FDA takes to a review a drug or biologic application, the greater the potential that complications will arise simply due to the duration of the process and evolving treatment standards.

Case in point: Sanofi and Regeneron Pharmaceuticals Inc.'s Kevzara (sarilumab), an interleukin-6 receptor blocker, approved May 22 for...

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