NEW YORK – Siemens Healthineers said Friday that it has received US Food and Drug Administration 510(k) marketing clearance for the use of its antithrombin activity assay as a companion diagnostic for Sanofi's Qfitlia (fitusiran), which was approved as a routine prophylaxis to prevent bleeding episodes in hemophilia patients.
The firm's Innovance Antithrombin assay is used before or during treatment with Qfitlia to monitor antithrombin activity levels and aid dosing decisions for patients ages 12 years and older. The test is used to aid the detection of genetic or acquired antithrombin deficiencies.
The FDA said Friday that it approved the use of Qfitlia to reduce or prevent bleeding episodes in patients with hemophilia A or hemophilia B with or without factor VIII or IX inhibitors. It noted that hemophilia A and B are genetic bleeding disorders that are caused by dysfunction or deficiency of coagulation factor VIII or IX, which results in loss of clotting ability following injury or surgery as well as spontaneous bleeding episodes.
The agency said that the Innovance Antithrombin assay is used to adjust the dose and frequency of Qfitlia injections to achieve antithrombin activity in the target range, reduce the risk of bleeding, and reduce the risk of excessive blood clotting.