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FDA identifies manufacturing issue with sarilumab

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According to a press release from Regeneron Pharmaceuticals Inc. and Sanofi, the FDA issued a complete response letter that has identified a manufacturing issue with the investigational biologic sarilumab, an interleukin-6 receptor antibody for the treatment of rheumatoid arthritis.

The letter — written in response to a biologics license application for sarilumab — identified manufacturing deficiencies at the Sanofi Le Trait facility in France, where sarilumab is filled and finished. Before the biologics license application can be approved, these deficiencies must be resolved, the letter said. In response, Sanofi has submitted a corrective action plan and will work with the FDA.

Reference:

www.news.sanofi.us/Sanofi-and-Regeneron-Receive-Complete-Response-Letter-from-FDA-for-Sarilumab-an-Investigational-Treatment-for-Rheumatoid-Arthritis