FDA accepts BLA for ropeginterferon alfa-2b for PV treatment

The U.S. Food and Drug Administration accepted a Biologics License Application for ropeginterferon alfa-2b (P1101) for the treatment of polycythemia vera without splenomegaly. The application is supported by data from the phase 3 PROUD/CONTI-PV trial, which compared the investigation drug against hydroxyurea/best available therapy and demonstrated a 70.5% complete hematological response rate at 36 months in the ropeginterferon alfa-2b group, versus 51.4% in the control group.