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

Sanofi SA SNY announced 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.
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