Remdesivir Emergency Authorization: FDA Update and Summary of Preliminary NIH Study Data
NOTE: Information and guidelines may change rapidly. Check in with listed references in ‘Learn More – Primary Sources’ to best keep up to date
SUMMARY:
The FDA has issued an emergency use authorization (EUA) for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. The approval is based on the NIH’s clinical trial showing “promising results.”
- An EUA is different than a full FDA approval
- An EUA is based on an FDA evaluation of evidence and risks vs potential or known benefits of of “unproven” products during an emergency
- The FDA states
The emergency use authorization allows for remdesivir to be distributed in the U.S. and administered intravenously by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease
Severe disease is defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator
It was determined that it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use
KEY POINTS:
NIH Remdesivir Trial
- RCT involving 1063 patients:
- Adaptive COVID-19 Treatment Trial (ACTT)
- Sponsored by the National Institute of Allergy and Infectious Diseases (NIAID)
- Multicentered (including US, UK, and Singapore)
- Started in February 2020
- Current primary endpoint: Being well enough for hospital discharge or returning to normal activity level
Preliminary Data
- Time to recovery
- Median time to recovery: 11 days for remdesivir group vs 15 days for placebo group
- 31% faster time to recovery in remdesivir group vs placebo (p<0.001)
- Mortality Rate
- 8.0% in remdesivir group vs 11.6% for the placebo group (p=0.059)
- “Suggests benefit” but not statistically significant
- Second (next) stage of trial
- Remdesivir in combination with another agent | Likely to be a janus kinase inhibitor
- One of the investigators (UK team) stated (April 30, 2020)
As far as the results are concerned, it’s cautious optimism
There is some effect but it is not a wonder effect
We have to find out when is the best time to give this drug, who benefits more
There is still a lot of data to come out of this trial
Learn More – Primary Sources:
NIH clinical trial shows Remdesivir accelerates recovery from advanced COVID-19
Covid-19: Remdesivir is helpful but not a wonder drug, say researchers (BMJ)
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