Swedish Orphan Biovitrum AB (publ) (SOBI.ST)
- PR Newswire
Phase 3 DISSOLVE Program of SEL-212 in Chronic Refractory Gout Meets Primary Endpoint: Swedish Orphan Biovitrum AB
Selecta Biosciences, Inc. (NASDAQ: SELB) and Sobi®, today announced positive topline results from the Phase 3 DISSOLVE I & II placebo controlled randomized clinical trials to determine safety and efficacy of two different dose levels of SEL-212 in adult patients with chronic refractory gout. The DISSOLVE I (the "US Study") met its primary endpoint, with 56% of patients receiving monthly doses of SEL-212 at 0.15 mg/kg achieving a response (defined as achievement and maintenance of reduction in se
- PR Newswire
Positive topline results from pivotal XTEND-Kids phase 3 study of efanesoctocog alfa in children under 12 years of age with haemophilia A: Swedish Orphan Biovitrum AB
Sobi® and Sanofi today announced that the XTEND-Kids phase 3 pivotal study evaluating the safety, efficacy and pharmacokinetics of efanesoctocog alfa as once-weekly prophylaxis in previously treated patients under 12 years of age with severe haemophilia A met its primary endpoint. No factor VIII inhibitors were observed in the 74 children enrolled in the study, of which 65 experienced at least 50 exposure days. Efanesoctocog alfa provided high sustained factor VIII levels throughout the weekly d
- PR Newswire
FDA approves once-weekly efanesoctocog alfa, a new class of high-sustained factor VIII therapy for haemophilia A: Swedish Orphan Biovitrum AB
Sobi® today announced that the US Food and Drug Administration (FDA) has approved efanesoctocog alfa [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], a first-in-class, high-sustained factor VIII replacement therapy for adults and children with haemophilia A. Efanesoctocog alfa is the first and only haemophilia A treatment that provides patients with normal to near-normal factor VIII activity levels for a significant part of the week with once-weekly dosing, resulting in su
