FDA accepts new drug application for daprodustat
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The FDA has accepted a new drug application for daprodustat, which was filed by GlaxoSmithKline plc, according to a press release.
Daprodustat was designed to treat patients with anemia of chronic kidney disease, using science that showed how cells sense and adapt to oxygen availability. The new drug application for daprodustat follows the ASCEND phase 3 clinical trials. As Healio previously reported, the five trials showed positive efficacy for daprodustat and all safety endpoints were met. Compared with the standard of care, daprodustat improved and/or maintained hemoglobin without increased major adverse cardiovascular events in intention-to-treat populations across both non-dialysis and dialysis patient settings.
In Japan, daprodustat is approved as Duvroq for patients with renal anemia, and the European Medicines Agency is reviewing the marking authorization application for the drug.
The FDA has assigned a Prescription Drug User Fee Act action date of Feb. 1, 2023, and GlaxoSmithKline plc intends to file more regulatory filings throughout 2022.
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