Benzinga | Jun 11, 2021 02:32PM EDT

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

* Sanofi SA's (NASDAQ: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.