PharmaEssentia Corp (TPE:6446) has submitted post-approval applications to Taiwan's Food and Drug Administration to expand the use of Besremi (ropeginterferon alfa-2b) and modify its dosing regimen for polycythemia vera (PV), according to a Friday filing to the Taiwan stock exchange.

The company has sought approval to use Besremi in all adult patients with essential thrombocythemia (ET), regardless of treatment line, broadening its current indication for patients resistant or intolerant to hydroxyurea.

It has proposed to change the PV dosing regimen from the current regimen of a starting dose of 100 mcg followed by 50 mcg increases every two weeks, to a higher initial dose and accelerated titration (HIDAT) regimen consisting of a starting dose of 250 mcg, increased to 350 mcg after two weeks, and further increased to the target dose of 500 mcg after another two weeks.

Besremi was approved in Taiwan in 2020 for adults with PV without symptomatic splenomegaly.