CSL Of Australia Gets U.S. FDA Panel Backing For Blood Disorder Drug
This article was originally published in PharmAsia News
Executive Summary
Australia's CSL won unanimous approval of a U.S. FDA advisory panel judging the safety of its Riastap plasma-based drug for treating congenital fibrinogen deficiency. The panelists recommended approval based on the drug's success in boosting a clotting protein associated with the rare blood disorder. They noted limited testing of the therapy, but the head of U.S. research and development said CSL plans to gather more data in post-market studies. The agency is expected to decide by Jan. 17. (Click here for more