Besremi (ropeginterferon alfa-2b), developed by Taiwanese drugmaker Pharma Essentia, obtained marketing approval in Korea. It is a next-generation interferon that acts directly on hematopoietic stem cells to treat polycythemia vera fundamentally.

On Wednesday, the Ministry of Food and Drug Safety approved the use of Besremi for the treatment of low-risk patients (limited to those requiring cytoreduction therapy) and high-risk patients with polycythemia vera without symptomatic splenomegaly.

The conventional interferon treatment has a short dosing cycle and causes many side effects. In contrast, Besremi causes fewer adverse reactions and has a two to four-week dosing cycle, making it easy for long-term treatment.

Polycythemia vera is a chronic, intractable, rare blood cancer in which red blood cells are produced excessively due to a mutated gene in the bone marrow.

The disease progresses slowly, showing no symptoms in the early stages. However, if not treated at the right time, it causes thrombosis and cardiovascular complications. It transforms into myelofibrosis or acute myeloid leukemia, which can be life-threatening in the long term.

The approval for Besremi was based on the results from the phase 3 PROUD/CONTINUATION-PV trial in Europe. Besremi showed sustained hematologic and molecular genetic responses in the trial. In addition, at year five, the drug reduced the JAK2 V617F allele burden to less than 10 percent in more than half of the Besremi-treated group, proving its potential as a fundamental treatment.

The most common adverse reactions were leukopenia (19.1 percent), thrombocytopenia (18.5 percent), arthralgia (12.9 percent), fatigue (12.4 percent), increased gamma-glutamyltransferase (GGT) (11.2 percent), influenza-like illness (10.7 percent), and myalgia (10.7 percent).

Ko-Chung Lin, CEO of Pharma Essentia, said he was pleased to release Besremi, a long-acting next-generation interferon treatment for polycythemia vera, in the Korean market.

“We will make further efforts through cooperation with key officials and the medical community so that Besremi can be provided smoothly for polycythemia vera patients in Korea.”