PharmaEssentia Corp. said that the U.S. Food and Drug Administration has approved BESREMi or ropeginterferon alfa-2b-njft for the treatment of adults with polycythemia vera.
PharmaEssentia noted that it is preparing to make BESREMi available in the coming weeks in the U.S.
BESREMi is monopegylated, long-acting interferon, which exhibits its cellular effects in polycythemia vera in the bone marrow. BESREMi was approved with a boxed warning for risk of serious disorders including aggravation of neuropsychiatric, autoimmune, ischemic and infections disorders.
Polycythemia vera is a rare, chronic and life-threatening blood cancer caused by a
mutation in stem cells in the bone marrow, resulting in the overproduction of blood cells. When this occurs, it puts a person at risk for serious health problems, including blood clots, stroke and heart attack.
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