Taiwanese pharmaceutical company PharmaEssentia Corp. has received approval from the U.S. Food and Drug Administration for its new drug that treats adults with a rare blood disease, the company said Monday.
The FDA granted the approval on Nov. 13 for the drug Besremi (ropeginterferon alfa-2b-njft, P1101) to treat polycythemia vera, a life-threatening blood cancer that causes the overproduction of red blood cells, the company said.
The green light will allow PharmaEssentia to venture into the United States market, and the company is preparing to make Besremi available to distributors in the U.S. in the coming 3-4 weeks, it said at an investor conference in Taipei on Monday.
The drug had already received orphan drug designation for the treatment of polycythemia vera in the United States, and with the FDA approval, PharmaEssentia will have seven years of Orphan Drug Exclusivity (ODE) in the U.S. market.
Before obtaining the FDA approval, P1101 had been approved in the European Union, Taiwan, Switzerland, Israel and South Korea for the treatment of the blood disease, the company said.
The PharmaEssentia’s flagship drug is the first product approved by the FDA for the treatment of all adults with polycythemia vera and is expected to be covered by most health insurance plans in the U.S., according to the company.
PharmaEssentia, meanwhile, has recruited 87 patients, more than half of the total it plans to recruit, for a global Phase 3 trial of its P1101 to treat essential thrombocythemia. It expects to recruit all the participants needed for the trial by the second quarter of 2022.
PharmaEssentia is a global pharmaceutical company founded by a group of Taiwanese-American scientists in August 2003.
Source: Focus Taiwan News Channel