GSK Confident Its ‘Last Drug Standing’ In Anemia Class Can Gain US Panel Backing
Safety Profile Will Be Closely Scrutinized
GSK could have the US market to itself if it can convince the expert panel of daprodustat’s safety, as rivals have fallen by the wayside.
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The US FDA turned down approval for vadadustat in chronic kidney disease anemia, in a complete response letter that unexpectedly included the dialysis-dependent indication.
The EU approval is good news for FibroGen and marketing partner Astellas, but was expected, and still leaves it pondering its future after FDA knock-back.
As anticipated, the FDA issued a complete response letter for roxadustat. While the drug is expected to win EU approval, it is unclear if FibroGen and AstraZeneca will be willing to fund another trial.