FDA issues Complete Response Letter for sutimlimab, an investigational treatment for hemolysis in adults with cold agglutinin...
November 13 2020 - 7:00PM
FDA issues Complete Response Letter for sutimlimab, an
investigational treatment for hemolysis in adults with cold
agglutinin disease
FDA issues Complete Response Letter for sutimlimab, an
investigational treatment for hemolysis in adults with cold
agglutinin
disease
* Complete Response Letter refers to
deficiencies from a pre-license inspection of a third-party
manufacturing facility
PARIS – November 14, 2020 - The
U.S. Food and Drug Administration issued a Complete Response Letter
(CRL) regarding the Biologics License Application (BLA) for
sutimlimab, an investigational monoclonal antibody for the
treatment of hemolysis in adults with cold agglutinin disease.
The CRL refers to certain deficiencies
identified by the agency during a pre-license inspection of a
third-party facility responsible for manufacturing. There were no
clinical or safety deficiencies noted in the CRL with respect to
the application. Satisfactory resolution of the observations by the
third-party manufacturer is required before the BLA can be approved
and Sanofi remains in close contact with the FDA and the
third-party manufacturer to reach a resolution in a timely
manner.
About Sanofi Sanofi is dedicated to
supporting people through their health challenges. We are a global
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illness with vaccines, provide innovative treatments to fight pain
and ease suffering. We stand by the few who suffer from rare
diseases and the millions with long-term chronic
conditions. With more than 100,000 people in 100 countries,
Sanofi is transforming scientific innovation into healthcare
solutions around the globe. Sanofi, Empowering Life |
Media Relations Contact
Sally BainTel.: +1 781-264-1091sally.bain@sanofi.com |
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Greco Investor Relations Main LineTel.: +33
(0)1 53 77 45
45investor.relations@sanofi.comhttps://www.sanofi.com/en/investors/contact |
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