Ropeginterferon for polycythaemia in EUApril 9, 2019
PharmaEssentia announced that the European Commission (EC) has approved ropeginterferon alfa-2b (Besremi) as monotherapy in adults for the treatment of polycythaemia vera (PV) without symptomatic splenomegaly.
The EU market authorization makes ropeginterferon alfa-2b the first and the only approved treatment for PV, independent of previous hydroxyurea exposure, based on phase III clinical data.
Ropeginterferon alfa-2b will be available as a solution for injection in a pre-filled pen in two dosage strengths of 250 microgram/0.5 ml and 500 microgram /0.5 ml.]
Ropeginterferon alfa-2b is a novel, long-acting, predominately single isomer mono-pegylated proline interferon with improved pharmacokinetic properties.
It is administered once every 2 weeks, or once every 4 weeks during long-term maintenance, and is the first interferon approved for PV.