FDA Expands Remdesivir EUA to All Patients Hospita
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Posted On: 08/30/2020 12:38:08 PM
FDA Expands Remdesivir EUA to All Patients Hospitalized with COVID-19
AUG 29, 2020 | COVID-19, EMERGENCY USE AUTHORIZATION, NEWS, REMDESIVIR
The U.S. Food and Drug Administration broadened the scope of the existing emergency use authorization (EUA) for the drug Veklury (remdesivir) to include treating all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of the disease. Previously, the drug was only available under the EUA for severe COVID-19 hospitalized cases per the May 2020 EUA authorization.
Why did the FDA make this ruling?
Based on the Agency’s ongoing review of the EUA, including its review of the totality of scientific information now available, they determined that it is “reasonable” to believe the antiviral may be effective for treating suspected laboratory-confirmed COVID-19 in all hospitalized adult and pediatric patients.
In utilizing risk-based analyzes, the Agency determines that the potential benefits of remdesivir outweigh the known and potential risks for these use cases.
A Compelling benefit?
TrialSite reported that the initial study used for the EUA had a controversial set of circumstances associated with the actions of sponsor Gilead, NIAID, and the U.S. FDA. Initially, the ACT-1 study’s endpoint was a reduction in the COVID-19 death rate. Near the end of the study, when it became clear to all that remdesivir had no impact, the study sponsor and regulators changed the primary endpoint to reducing recovery time. Ultimately the data revealed a reduction in hospitalization duration from 15 days down to 11 days. This is better than nothing, but the fact that the sponsors changed the endpoint with just about two weeks left during the study was an unorthodox and controversial move.
Shortly thereafter, Dr. Anthony Fauci, director of NIAID, declared that remdesivir was a new standard of care. But of course, just a few sentences later also declared this was “no knockout drug.”
However, because of that FDA EUA ruling, remdesivir became the only drug in the U.S., and shortly thereafter, Europe and Japan, that could be used to treat COVID-19: albeit for only those hospitalized with more severe cases. But thanks to the EUA and Gilead’s pricing, top analysts predicted Gilead could generate a windfall of between $1 and $3 billion over the next 12 months: during pandemic conditions with a drug that wasn’t even fully approved!
Now more hospitalized patients with COVID-19 can access the drug via the EUA.
AUG 29, 2020 | COVID-19, EMERGENCY USE AUTHORIZATION, NEWS, REMDESIVIR
The U.S. Food and Drug Administration broadened the scope of the existing emergency use authorization (EUA) for the drug Veklury (remdesivir) to include treating all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of the disease. Previously, the drug was only available under the EUA for severe COVID-19 hospitalized cases per the May 2020 EUA authorization.
Why did the FDA make this ruling?
Based on the Agency’s ongoing review of the EUA, including its review of the totality of scientific information now available, they determined that it is “reasonable” to believe the antiviral may be effective for treating suspected laboratory-confirmed COVID-19 in all hospitalized adult and pediatric patients.
In utilizing risk-based analyzes, the Agency determines that the potential benefits of remdesivir outweigh the known and potential risks for these use cases.
A Compelling benefit?
TrialSite reported that the initial study used for the EUA had a controversial set of circumstances associated with the actions of sponsor Gilead, NIAID, and the U.S. FDA. Initially, the ACT-1 study’s endpoint was a reduction in the COVID-19 death rate. Near the end of the study, when it became clear to all that remdesivir had no impact, the study sponsor and regulators changed the primary endpoint to reducing recovery time. Ultimately the data revealed a reduction in hospitalization duration from 15 days down to 11 days. This is better than nothing, but the fact that the sponsors changed the endpoint with just about two weeks left during the study was an unorthodox and controversial move.
Shortly thereafter, Dr. Anthony Fauci, director of NIAID, declared that remdesivir was a new standard of care. But of course, just a few sentences later also declared this was “no knockout drug.”
However, because of that FDA EUA ruling, remdesivir became the only drug in the U.S., and shortly thereafter, Europe and Japan, that could be used to treat COVID-19: albeit for only those hospitalized with more severe cases. But thanks to the EUA and Gilead’s pricing, top analysts predicted Gilead could generate a windfall of between $1 and $3 billion over the next 12 months: during pandemic conditions with a drug that wasn’t even fully approved!
Now more hospitalized patients with COVID-19 can access the drug via the EUA.
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