Gilead wins FDA nod to use Veklury for COVID-19 in liver disease
MikeMareen/iStock Editorial via Getty Images

Gilead Sciences (NASDAQ:GILD) announced Thursday that the U.S. FDA approved its request to expand the label for its COVID-19 therapy, Veklury (remdesivir), allowing its use across all stages of liver disease.
The supplemental new drug application (sNDA) that led to the FDA's decision was backed by data from a Phase 1 study in which Gilead (GILD) tested Veklury in patients with hepatic impairment.

Despite the approval, the FDA still recommends hepatic laboratory testing for patients before initiating Veklury or during the treatment, as appropriate. The regulator also recommends discontinuation if there is a rise in liver enzymes such as alanine transaminase. 

Veklury, the first COVID-19 therapy greenlighted in the U.S., was approved for use in patients with severe renal impairment in July.



More on Gilead 

Gilead Sciences: Mixed Signals, Again
Gilead Sciences Q2 Earnings: 'Transitional' Quarter Delivers Mixed Results

Gilead Sciences, Inc. (GILD) Q2 2023 Earnings Call Transcript
Gilead: Assessing How Shares Will Trade Over Upcoming Months (Technical Analysis)
Gilead announces FDA partial hold on leukemia trial
Gilead and Tentarix partner to develop protein therapeutics
Gilead boosts 2023 sales projection but cuts EPS outlook
Earnings data for Gilead Sciences
Dividend scorecard for Gilead Sciences