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news.CSL Behring, a developer of plasma protein biotherapeutics, has announced that the FDA has granted marketing approval for RiaSTAP, the first and only treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.
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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.