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On October 22nd, the FDA officially approved The Gilead antiviral drug Veklury (remdesivir) for COVID-19 treatment for adults and children 12 years of age and older who weigh at least 40 kg and require hospitalization.
fda press release, Veklury is currently the only FDA-approved COVID-19 therapy in the United States.
this approval does not include people authorized to use Veklury under the Emergency Use Authorization (EUA), originally issued on 1 May 2020, and patients weighing 3.5-40 kg can continue to use it under emergency authorization.
veklury's approval is based on the results of three randomized controlled clinical trials that included patients hospitalized for the severity of COVID-19.
randomized, double-blind, placebo-controlled clinical trial conducted by the U.S. National Institute of Allergy and Infectious Diseases assessed the time it takes patients to recover from COVID-19 within 29 days of treatment.
the trial looked at 1,062 patients admitted to hospital with mild, moderate and severe COVID-19 who received Veklury (541) or placebo (521), plus standard treatment, respectively.
10 days for COVID-19 healing in the Veklury group and 15 days in the placebo group, the difference was statistically significant.
, the Veklury group was also statistically significantly more likely to improve clinically on the 15th day than the placebo group.
In addition, according to Gilead's june prices in developed countries such as the United States, a course of treatment at Rydersiwe costs between $2,340 (about 16,000 yuan) and $3,120 (about 21,000 yuan), depending on the country and the type of insurance.
, the FDA's approval contradicts the World Health Organization's findings.
At a regular WHO briefing on 16 October on new coronary pneumonia, WHO Director-General Tan Desser said the interim results of the Solidarity Trials showed that Redsivir, hydroxychloroquine, Lopinavir/Litonave and interferon therapy appeared to have little effect on the 28-day mortality rate or the course of hospitalization in hospitalized patients.
WHO trials showed that Redsywee had little effect in severe cases, with 301 deaths among 2,743 severe patients in the Redsiway group and 303 deaths among 2,708 severe patients in the control group;
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