CSL Behring Receives ODE for RiaSTAP, First and Only Approved Treatment of Acute Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency

CSL Behring has been informed by the U.S. FDA that because RiaSTAP is the first FDA-approved treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, the company is entitled to seven years of orphan-drug exclusivity.

The details can be read here.