The FDA explained that Redsiway's approval was based on a negative recommendation from the Who

In this article, the FDA describes the basis for FDA approval of Redsyway (brand name: Veklury) and the interpretation of the results of the WHO SOLIDARITY trial (Unity Trial).
FDA stressed that under FDA law, approval of a new drug requires substantial evidence of the effectiveness and safety of the drug for its intended use.
redsiwe approved for the treatment of COVID-19 inpatients in compliance with this legal and scientific standard.
approval, the FDA says randomized controlled trials are a gold standard for evaluating the safety and effectiveness of drugs.
FDA's approval of Redsiway was an independent, in-depth fda analysis of data from three randomized, controlled clinical trials.
include the ACTT-1 trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) and the SIMPLE trial (GS-US-540-5774 and GS-US-540-5773).
FDA said, "THE ACTT-1 test submitted by NIAID provides the most compelling evidence of effectiveness due to its rigorous test design."
" and the FDA presents the basis for approval for each of the three trials.
ACTT-1 trial was a randomized, placebo-controlled, double-blind trial in which 1062 patients with mild, moderate, and severe COVID-19 were admitted to hospital with Redsyve (n-541) or a placebo (n-521) and provided standard care.
the main objective of the ACTT-1 trial was to observe the recovery time of inpatients.
rehabilitation is defined as being discharged from a hospital or still hospitalized without the need for oxygen and without the need for continuous medical care.
10 days in the Redsiway group recovered from COVID-19, while the placebo group had 15 days, and the difference was statistically significant.
were also statistically significantly higher in the 15th day of the Redsiway group than in placebo.
11 percent overall mortality rate in the Redsiway group and 15 percent in the placebo group, a difference that was not statistically significant.
GS-US-540-5774 is a randomized, open-label multi-center clinical trial for moderate COVID-19 hospitalized adult subjects.
trial compared the effects of Redsyway therapy for 5 days (n-191) and Redsiway therapy for 10 days (n-193) and standard care (n-200).
researchers assessed the subject's clinical status on day 11.
overall, subjects in the 5-day Redsyway treatment group were statistically significantly more likely to see an improvement in COVID-19 symptoms on day 11 than those in the subject group who received only standard care.
the 10-day Redsiver treatment group had a better numerically improved symptom, but there was no statistically significant difference, compared to the subject group that received only standard care.
GS-US-540-5773 is a randomized, open-label multi-center clinical trial for adult subjects hospitalized with severe COVID-19.
trials compared the effects of Redsiway therapy for 5 days (n-200) and Redsiway therapy for 10 days (n-197).
researchers assessed the subject's clinical status on day 14.
overall, subjects in the 5-day group were similar to those in the 10-day group who had a similar rate of improvement in COVID-19 symptoms, with no statistically significant differences, and no statistically significant differences in recovery and mortality rates between the two groups.
FDA said the review of the three experimental scientific evidence supported the FDA's decision to meet the substantive validity evidence and safety certification standards required by Redsiway's approval of the new drug.
the WHO Solidarity Trial and then the FDA discussed the results of the WHO Solidarity Trial.
FDA said the trial, an open-label, randomized trial hosted by the WHO, compared the differences between different research interventions for COVID-19 inpatients and the use of standard care only.
drug studied in the U.S. Drug Solidarity trial is Redsyvir.
objective of the unitedness trial is to assess the impact of treatment interventions on mortality in hospitals.
, as in the ACTT-1 trial discussed above, there was no statistically significant difference in mortality between the Redsyway and standard care groups.
while both the Solidarity Trial and the ACTT-1 Trial have helped us understand the interventions that can help treat COVID-19, the trial design and main objectives of the two clinical trials are different.
ACTT-1 design (randomized, placebo-controlled, double-blind) is better suited to rigorously assess recovery time than trials with open label design (e.g., solidarity trials).
based on the results of the ACTT-1 trial, redsiway has been shown to benefit patients, including shorter recovery times and a higher risk of clinical improvement.
the results of the Solidarity trial did not refute these findings, which benefited patients.
the end, the FDA said that drug oversight goes beyond approval, and that the FDA has legal authority to ensure the safety, effectiveness and high quality of approved and marketed drugs, including Redsyve.
fda also acknowledges that the FDA does not have the authority to regulate drug prices, which are determined by drugmakers and distributors.
FDA does not take potential pricing into account when reviewing the effectiveness, safety, and quality of the drug.
This statement on pricing is in response to the WHO's comprehensive consideration of the "relatively high cost and resource impact associated with Redsyve (requires intravenous injection)" when it announced that it would not recommend the use of Redsiway for coviD-19.
know the forest - pepper