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Sanofi’s Enjaymo (sutimlimab-jome) Receives the US FDA’s Approval for the Treatment of Cold Agglutinin Disease

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Sanofi’s Enjaymo (sutimlimab-jome) Receives the US FDA’s Approval for the Treatment of Cold Agglutinin Disease

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  • The approval was based on the P-III (CARDINAL) study to evaluate Enjaymo in 24 patients with CAD. Patients continued on Enjaymo in an extension study upon the completion of 26wk. treatment period
  • The study met its 1EPs & 2EP i.e., patients met the composite 1EPs criteria (54%), 63% achieved a Hgb ≥ 12 g/dL or an increase of 2g/dL; 71% remained transfusion-free after 5wk., 92% did not use other treatments & a mean increase in Hgb level @ 26wk., reduction in bilirubin levels
  • The product will be available in the US in the coming wks.  Enjaymo Patient Solutions provides access to eligible patients & enables disease education, financial, co-pay assistance programs & other support services

Ref: Sanofi | Image: Sanofi

Click here to­ read the full press release 

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