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The results from Phase 3 clinical trial SIMPLE were published in the Journal of the American Medical Association (JAMA) on August 21, 2020 and confirmed the first-line results previously published on June 1, 2020.
end point of the test was the assessment of the patient's symptoms using a level 7 scale on the 11th day.
trial results found that patients who received a random five-day course of Veklury plus standard treatment were 65 percent more likely to improve their clinical status than patients who received only standard treatment.
for patients in the Veklury group who received a 10-day course of treatment, there was no statistical difference between the improvement in clinical status on the 11th day compared to the standard treatment group.
As understanding of the effectiveness of Veklury's efforts to improve outcomes in a range of COVID-19 patients deepens, we welcome the FDA's decision to expand emergency use authorizations," said Dr. Merdad Parsey, Chief Medical Officer of Gilead Sciences.
fda's action today allows doctors to consider a wider range of eligible patients for Veklury treatment.
" References: s 1' Gilead's Investigational Antiviral Veklury® Receives U.S. Food and Drug Administration Use Authorization for The Treatment of Patients With With Moderate COVID-19. Retrieved August 28, 2020, from.