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CompilationFan Dongdong
Eight months after the failure of the last listing application, Pharma Essentia successfully alleviated the concerns of the US FDA.
In March of this year, the U.
The US FDA approval is based on the safety of PEGINVERA and PROUD/CONTINUATION-PV studies and the efficacy data from the PEGINVERA clinical research program
The injected drug is approved for the treatment of adult patients with polycythemia vera, a rare blood disease that causes blood to thicken and affects approximately 6,200 people in the United States each year
In addition, Pharma Essentia said that the US FDA’s previous refusal was due to the delay of pre-approval inspections of its manufacturing plant in Taiwan Province of China due to travel restrictions on the COVID-19 pandemic
The therapy can bind to interferon receptors and trigger the process of reducing red blood cell production in the bone marrow
In terms of competitors, Incyte's Jakafi was approved as a second-line treatment for polycythemia vera, while Besremi approved the first-line treatment this time
Reference source: Second time's a charm for PharmaEssentia as FDA approves Besremi to treat rare blood cancer
