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AkaRx announced that its DOPTELET (Avatrombopag) has been approved by the State Drug Administration (NMPA) to treat platelet reduction in adult chronic liver disease (CLD) patients who plan to undergo surgeryDoptelet is an oral platelet-producing (TPO) receptor agonisant taken with foodDoptelet has been approved by the U.SFood and Drug Administration (FDA) and the European Medicines Agency (EMA) for platelet reduction in adult chronic liver disease patients who plan surgeryIn June 2019, Doptelet was approved by the FDA for the treatment of adult patients with chronic immunoplatelet reduction (ITP) who have under-responded to previous treatmentsMahmood Ladha, President and Head of Dova, said: 'DOPTELET's approval of NMPA in China marks another important milestoneDOPTELET is currently the first approved treatment for this indication in China, providing patients with a safe and effective oral drug to replace platelet infusions to increase platelet count to target levels'
this approval is based on safety and effectiveness data for two global Phase 3, double-blind, placebo-controlled trials for severe platelet reduction (platelet counting is below 50000/?L)Both studies showed that DOPTELET outperformed placebo in both 40 mg and 60 mg of treatment groups
