Sanofi: FDA issues response letter for sutimlimab
(CercleFinance.com) - Sanofi announces that the US FDA has issued a complete response letter (CRL) regarding the biologic license application for sutimlimab, an investigational drug for the treatment of hemolysis in adult patients with cold agglutinin disease.
This complete response letter relates to deficiencies that identified by a pre-licensing inspection of the license application conducted at a third-party manufacturing facility. However, no clinical or safety deficiencies were noted.
Satisfactory resolution of the deficiencies by the third-party manufacturer is necessary for the license application to be approved. Sanofi is working closely with the FDA and the third-party manufacturer to achieve such resolution as soon as possible.
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This complete response letter relates to deficiencies that identified by a pre-licensing inspection of the license application conducted at a third-party manufacturing facility. However, no clinical or safety deficiencies were noted.
Satisfactory resolution of the deficiencies by the third-party manufacturer is necessary for the license application to be approved. Sanofi is working closely with the FDA and the third-party manufacturer to achieve such resolution as soon as possible.
Copyright (c) 2020 CercleFinance.com. All rights reserved.