Avigen's Coagulin-B fast-tracked in USA

Avigen has been awarded priority review status by the US Food and DrugAdministration for Coagulin-B, its adeno-associated viral therapy which delivers the gene for human coagulation Factor IX, for the treatment of patients with moderate-to-severe hemophilia B.

The company also notes that Coagulin-BV has been designated an orphan drug for this indication, with the status covering AAV vectors used for both intramuscular and hepatic delivery.

Avigen started a Phase I trial of Coagulin-B administered straight into the hepatic artery last month, with results expected before the end of the year. The study will look at circulating Factor IX in patients and assess the patients' requirement for injections of the current recombinant form of the protein. A Phase I study of intramuscular delivery has already been completed, and this demonstrated that the gene therapy could achieve low levels of circulating Factor IX in some patients.