Saturday, October 29, 2016
Sanofi SA and Regeneron Pharmaceuticals Inc on Friday said U.S. regulators had declined to approve their experimental treatment for rheumatoid arthritis because of manufacturing deficiencies.
The companies, in a release, said the U.S. Food and Drug Administration identified the deficiencies during a routine inspection of a Sanofi plant in France where the drug, sarilumab, is filled and finished, one of the last steps in the manufacturing process.
Sanofi said it had submitted a comprehensive correction plan to the FDA and is taking corrective actions.
Source : reuters.com
