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GSK: FDA Sets Advisory Committee Meeting To Review NDA For Daprodustat - Quick Facts

GSK plc (GSK,GSK.L) said the FDA will convene a meeting of the Cardiovascular and Renal Drugs Advisory Committee to review the New Drug Application for daprodustat for the potential treatment of anaemia due to chronic kidney disease in adult patients on dialysis and not on dialysis. The date for the advisory committee meeting is 26 October 2022.

In June 2022, Duvroq or daprodustat tablets were approved by Japan's Ministry of Health, Labour and Welfare for patients with renal anaemia. In March 2022, the European Medicines Agency validated the marketing authorisation application for daprodustat, which is currently under regulatory review.

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