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Sanofi's Fitusiran Prophylaxis Cuts Bleeds By 61% In Hemophilia Patients

·1 min read
  • Sanofi SA (NASDAQ: SNYannounced data from the Phase 3 ATLAS-PPX study of once-monthly fitusiran (80 mg) in severe hemophilia A or B patients.

  • The study included previously treated patients with a prior factor or bypassing agent (BPA) prophylaxis.

  • The study met the primary endpoint and demonstrated fitusiran prophylaxis significantly reduced bleeding episodes compared to prior factor or BPA prophylaxis.

  • The overall median annualized bleeding rate (ABR) was 0.0 for fitusiran prophylaxis, compared to a median ABR of 4.4 with prior prophylaxis.

  • Fitusiran prophylaxis resulted in a statistically significant reduction in estimated ABR of 61.1% vs. factor or BPA prophylaxis.

  • 63.1% of the patients treated with fitusiran experienced zero treated bleeds compared to 16.9% with a prior factor or BPA prophylaxis.

  • Consistent with the previously identified risk of fitusiran, suspected or confirmed thromboembolic events were reported in 2 participants.

  • Sanofi is currently investigating the efficacy and safety of fitusiran under an amended protocol which includes lower doses and a less frequent dosing regimen, maintaining an antithrombin target range of 15-35% in all ongoing studies.

  • Price Action: SNY shares closed 0.12% lower at $50.16 on Friday.

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