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Sanofi Reveals Late-Stage Data For Fitusiran In Hemophilia Patients


Benzinga | Dec 14, 2021 12:48PM EST

Sanofi Reveals Late-Stage Data For Fitusiran In Hemophilia Patients

Sanofi SA (NASDAQ:SNY) presented data from two Phase 3 studies of fitusiran for the prophylactic treatment with hemophilia A or B, with or without inhibitors.

* Data were shared at the American Society of Hematology (ASH) Annual Meeting.

* Fitusiran, an RNAi drug designed to silence the gene that overproduces a protein responsible for clotting suppression.

* Fitusiran cut patients' annualized bleeding rate (ARB) rate by 89% over control, demonstrating prophylactic for bleeding episodes as a once-monthly injection.

* In this Phase 3 study, dubbed ATLAS-A/B, 50.6% of patients treated with fitusiran had zero treated bleeds during the study compared with just 5% of patients in the on-demand arm.

* Sanofi revealed safety data from ATLAS-A/B with 19% of patients in the fitusiran arm reporting abnormally high levels of ALT and AST proteins. Meanwhile, there were no reported cases of thrombosis.

* Sanofi reported updated results from ATLAS-INH showing 24.4% of patients in the study had abnormally high levels of ALT/AST, and two patients presented suspected or confirmed thrombosis.

* Price Action: SNY shares are down 1.05% at $48.26 during the market session on the last check Tuesday.

* Check out our coverage of the American Society of Hematology (ASH) Annual Meeting 2021 here.







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