FDA rejects Sarilumab due to production facility issues

pharmafile | October 31, 2016 | News story | Manufacturing and Production, Sales and Marketing FDA, Regeneron, Sanofi, sarilumab 

The US Food and Drugs administration has decided to reject the application for Sarilumab, Regeneron and Sanofi’s rheumatoid arthritis treatment, on the basis of issues identified at a Sanofi facility where the drug’s production is finished.

The FDA stated this intention in a complete response letter to both companies. The organisation did not put forward any concerns regarding the safety or efficacy of the IL-6R antibody, but cited “certain deficiencies” at a Sanofi facility in Normandy, France. The company is in the process of enacting corrective measures:

“Satisfactory resolution of these deficiencies is required before the BLA can be approved,” the company noted. “Sanofi submitted a comprehensive corrective action plan to the FDA and is implementing the corrective actions specified in that plan.  Sanofi is working closely with the FDA towards a timely resolution that addresses these concerns.” The company aims to resolve the issues by 29 March when its atopic dermatitis treatment dupilumab is due for approval.

Neither company has expressed concern over whether the delay will affect valuation of the drug, with projections set at $1 billion in sales by 2025. A Marketing Authorisation Application was accepted for the drug by the European Medicines Agency (EMA) earlier this year.

Matt Fellows

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