Gilead's COVID drug Veklury gets EMA greenlight for expanded use
Bill Oxford

A committee of the European Medicines Agency (EMA) recommended the expanded approval of Gilead Sciences (NASDAQ:GILD) Veklury (remdesivir) in patients with COVID-19 with severe kidney impairment, including those on dialysis.
Gilead said the positive opinion by the EMA's Committee for Medicinal Products for Human Use (CHMP) for Veklury's use in people with severe renal impairment was based on data from a phase 1 pharmacokinetic study and results from a phase 3 trial called REDPINE.

The European Commission (EC), which generally follows the opinion of the CHMP, will make a final decision on the drug's expanded approval.
If approved, Veklury will become the first and only authorized antiviral COVID-19 therapy that can be used across all stages of kidney disease, according to Gilead.
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