FDA extended emergency use authorization of Veklury to all hospitalized patients
The U.S. Food and Drug Administration has approved Veklury (remdesivir) for all hospitalized adult and pediatric COVID-19 patients irrespective of the severity of the disease.
In May 2020, the drug received emergency use authorization (EUA) for COVID-19 patients who are suffering from severe disease. Now, FDA has extended the emergency use authorization to all hospitalized patients.
The emergency use authorization is based on randomized, double-blind, placebo-controlled trial which enrolled 1,062 hospitalized patients with mild, moderate, and severe COVID-19 infection. Patients were randomized into two arms, Veklury (n=541) arm and placebo (n=521), plus standard of care arm. Recovery is considered as those patients who were discharged from the hospital or those who don’t need medical care. The median duration of time for the recovery is ten days in Veklury arm compared to 15 days in placebo + standard of care arm. Odds of clinical improvement are significantly higher in Veklury arm compared to the placebo arm. The trial was conducted by the National Institute of Allergy and Infectious Diseases.
In another trial (Study GS-US-540-5774), patients were randomized to receive Veklury for five days and placebo for ten days. The outcomes were measured after 11 days; patients improving the symptoms were significantly higher in Veklury arm compared to the placebo group.
Factors to consider while administrating Veklury:
Veklury can be administered after any time once the patients test positive for COVID19
Adults and pediatrics must have determined glomerular filtration rate and neonates must be determined for serum creatinine for initiating the treatment with Veklury
Hepatic laboratory testing is mandatory before initiating the treatment
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