Phase 3 Results Announced for ATryn for the Prevention of VTE in Pregnancy
rEVO Biologics announced the results of a major retrospective study analysis of its phase 3 studies which demonstrate that pregnant patients with hereditary antithrombin deficiency (HD) benefit from ATryn Antithrombin (Recombinant) therapy to prevent venous thromboembolic events (VTE). ATryn is a recombinant antithrombin indicated for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients.
The study was a retrospective analysis to assess the safety and efficacy of ATryn based on pooled data from pregnant AT-deficient women who were enrolled in two Phase 3 clinical trials conducted in 28 sites across the US, Europe, Canada, and Australia. Dosing began up to 24 hours before scheduled Cesarean delivery or on admission for labor and continued for 3–14 days. Patients were assessed for the incidence of VTE and adverse events (AEs.). Results of the retrospective analysis demonstrated that there were no confirmed VTEs reported between initiation and 7 (±1) days after discontinuation of ATryn therapy.For more information call (800) 610-3776 or visit www.atryn.com