rEVO Biologics announces results from Atryn phase 3 studies on pregnant AT-deficient women
Published on February 16, 2013 at 4:56 AM
rEVO Biologics announced today the results of a major retrospective study analysis of its pivotal 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).
Presented as a poster at the February 2013 meeting of the Society for Maternal-Fetal Medicine (SMFM), this integrated analysis was led by Dr. Michael Paidas, professor at Yale School of Medicine and co-director of the Yale Women and Children's Center for Blood Disorders. "This represents the largest known cohort of pregnant patients with HD treated with antithrombin for the prevention of VTE during a high-risk situation," Dr. Paidas commented.
HD is a blood disorder that affects between one out of every two to five thousand Americans. People with hereditary AT deficiency have a twenty-fold higher risk for VTE events throughout their lifetime. Women with HD are at high risk for VTE during pregnancy and after delivery.
The purpose of the study was 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 United States, Europe, Canada, and Australia. Dosing began up to 24 hours before scheduled Cesarean delivery or on admission for labor and continued for 3 to 14 days. Patients were assessed for the incidence of VTE and adverse events (AEs).
Results of the retrospective analysis showed that no confirmed VTEs were reported between initiation and 7 (±1) days after discontinuation of ATryn therapy. Reported AEs were similar to those expected in pregnant patients during and immediately after delivery. No AEs related to ATryn therapy were reported in the neonates. The study concluded that therapy with ATryn, administered via a bolus loading dose followed by maintenance infusion, is safe and effective for use in pregnant patients with HD.
According to Dr. Simon Lowry, Vice President of Medical Affairs at rEVO Biologics, "This study continues to underscore the important role of ATryn in the management of pregnant patients with hereditary antithrombin deficiency. rEVO Biologics is committed to develop new therapies for patients with rare diseases."