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Biotech Stocks Facing FDA Decision In February 2023

GlaxoSmithKline
GlaxoSmithKline

The FDA decision on GlaxoSmithKline plc’s (GSK) Daprodustat, proposed for the treatment of patients with anaemia of chronic kidney disease is anticipated on February 1, 2023.

Chronic kidney disease (CKD) is an increasing global health burden affecting 700 million patients worldwide. It is estimated that one out of every seven patients with CKD also develop anaemia, which leads to increased illness, death, and a poor quality of life.

An FDA panel, which scrutinized Daprodustat last October, voted 13 to 3 that the benefits of treatment with Daprodustat outweigh the risks for adult dialysis patients with anemia of chronic kidney disease. However, the panel did not recommend approval of Daprodustat in adult non-dialysis patients with anemia of CKD, with a 5 to 11 vote.

The FDA usually follows the recommendations of its panels although it is not required to do so.

GSK closed Friday’s trading at $35.30, down 0.11%.