BRIEF—PharmaEssentia expecting Besremi approvals

Taipei, Taiwan-based biotech PharmaEssentia is expecting a regulatory nod in Japan, as soon as by June, for Besremi (ropeginterferon alpha-2b), for the treatment of the rare blood cancer polycythemia vera.

The company said Japan's Pharmaceuticals and Medical Devices Agency (PMDA) completed facility inspections in December 2022.

PharmaEssentia is also waiting for an approval in China, which the company estimates is home to about 400,000 PV patients.

Besremi gained approval in the USA in 2021.

PharmaEssentia plans to invest in studies in the USA to explore dosing for low-risk PV patients as a way to increase sales.

The drug was also approved in Europe in 2019.