The primary analysis of the P-III (HAVEN 6) study evaluating the safety, efficacy, PK & PD of Hemlibra in 72 patients with mod. or mild haemophilia A without factor VIII inhibitors
The results showed an effective bleed control & the therapy maintained low treated bleed rates, 66.7% of patients experienced no bleeds; no spontaneous bleeds (81.9%); no joint bleeds (88.9%), and model-based ABR remained low throughout the evaluation period at 0.9. The safety profile was consistent with findings across multiple subpopulations from prior (HAVEN) & (STASEY) studies with no new safety signals
1 patient experienced a grade one thromboembolic event unrelated to Hemlibra, no deaths or cases of thrombotic microangiopathy were reported
Ref: Roche | Image: Roche
