Sanofi's Sutimlimab Hits Endpoint Goal In Rare Anemia Study After FDA Rejection

Sanofi SA’s SNY sutimlimab nailed all three of its primary endpoints in its Phase 3 CADENZA study for patients with cold agglutinin disease. This rare disorder can cause severe anemia without a recent history of blood transfusion.
Topline results will be presented at the European Hematology Association 2021 Congress.
The results of the 42-subject study showed that sutimlimab was able to reduce the destruction of red blood cells (haemolysis) seen in patients with CAD within one week of starting treatment.
The drug aced all its endpoint marks, including an improvement in hemoglobin over 1.5 g/dL from baseline at weeks 23, 25, and 26; avoiding transfusions between weeks five and 26; and avoiding starting new CAD-related therapies between weeks five and 26.
That was achieved in 73% of patients, compared to 15% of the placebo group.
Sutimlimab also hit its secondary endpoints, which included improvement from baseline in hemoglobin, bilirubin, lactate dehydrogenase levels, and quality of life.
The FDA had turned down Sanofi’s initial attempt to secure marketing approval for sutimlimab last November, based on the earlier phase 3 CARDINAL trial results in 24 patients, stemming from deficiencies identified at a third-party manufacturer of the drug.
Price Action: SNY shares are down 0.30% at $53.62 during the market trading session on the last check Friday.