Is Enasidenib on the market?

On August 1, 2017, the U.S. Food and Drug Administration (FDA)approved ensidipine (Enasidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with specific gene mutations. The drug was approved for use as a companion diagnostic, the real-timeIDH2 test, to detect specific mutations in the IDH2 gene in patients with acute myeloid leukemia. Ensidipine is sold under the trade name Idhifa and is not currently available in other regions.

Ensidipine is a selective inhibitor of IDH2, a mitochondrial-localized enzyme involved in a variety of cellular processes, including hypoxic adaptation, histone demethylation, and DNA modification. In contrast, mutant forms of the IDH2 enzyme mediate a neomorphic activity that is associated with DNA and histone hypermethylation, altered gene expression, and prevention of cellular differentiation of hematopoietic progenitor cells. Ensidipine mainly targets mutant IDH2 variants R140Q, R172S and R172K, and its potency is higher than that of the wild-type enzyme form Label. Inhibition of the enzyme results in reduced 2-hydroxyglutarate (2-HG) levels and promotes proper differentiation and clonal proliferation of myeloid cells.

Ensiidi plain investigational medicine is not currently on the market in the country, nor is it covered by medical insurance. The price of ensidipine plain medicine when it is launched overseas is very high, and the price of each box may be around 30,000 yuan (the price may fluctuate due to the exchange rate). Currently, there are cheaper generic encidipine drugs produced by other pharmaceutical companies overseas. For example, the price of Specification50mg*60 tablets produced by a Bangladesh pharmaceutical factory may be around 4,000 yuan per box (the price may fluctuate due to exchange rates). Its drug ingredients are basically the same as those of the original encidipine generic drug.