RiaSTAP is not indicated to treat dysfibrinogenemia. Approval was based on a pivotal Phase II prospective, open-label pharmacokinetic (PK) and safety study using maximum clot firmness (MCF) as a surrogate endpoint for hemostatic efficacy.
According to the company, results from the 15-patient PK study showed that median fibrinogen plasma antigen levels and median fibrinogen plasma activity levels reached a maximum within 30 minutes (antigen) to one hour (activity) post-infusion and decreased continuously afterward. Results also demonstrated a highly significant (p<0.0001) mean improvement in MCF from baseline to one hour post-infusion following RiaSTAP treatment.
CSL Behring is studying RiaSTAP in an ongoing post-marketing commitment study to further demonstrate safety and hemostatic efficacy.
Robert Lefebvre, general manager and vice president of US commercial operations at CSL Behring, said: The FDA approval of RiaSTAP underscores CSL Behring’s ongoing commitment to addressing the unmet needs of patients with rare and serious bleeding disorders.
As a leader in developing safe, effective and high-quality biologic therapies, CSL Behring is pleased to introduce a product for congenital fibrinogen deficiency that provides a new therapeutic option to support hemostasis and clot stability.