PharmaEssentia Corp (藥華醫藥) on Monday said that Besremi (Ropeginterferon alfa-2b), its treatment for people with polycythemia vera, a rare form of blood cancer, has gained marketing approval from Taiwan's Food and Drug Administration (FDA).
It was the drug’s second regulatory approval, following approval from the European Medicines Agency in February last year.
PharmaEssentia would soon begin to mass produce the drug, it said in a statement, adding that it would apply to the National Health Insurance Administration to have the drug included in the National Health Insurance (NHI) system.
There are about 3,000 people with polycythemia vera in Taiwan and the company plans to offer the drug to those who can pay for it out of pocket until it is accepted into the NHI system, it said.
Each dose of Besremi sold for about 3,000 euros (US$3,362) in Europe last year, the company said, adding that the local price has yet to be decided.
The company submitted the application for Besremi to Taiwan's FDA on July 31 last year, saying that it took the regulator a relatively shorter review period to give it the green light.
PharmaEssentia said that after submitting an application in March, it expects the drug to gain approval from the US Food and Drug Administration at the beginning of next year.
The US regulator on May 22 gave approval for PharmaEssentia to test Besremi for use against COVID-19 under the Coronavirus Treatment Acceleration Program.
The interferon drug modulates immune response by interfering with viral proliferation.
The firm plans to recruit 40 volunteers to test if the drug can reduce the possibility of a COVID-19 infection, it said.
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