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  • Treatment.Covid-19: Encouraging data from an international trial with the antiviral remdesivir

The US regulatory agency FDA has issued an emergency authorization for the use of the antiviral in research remdesivir, by the North American Gilead, for the treatment of laboratory-confirmed or suspected Covid-19 in hospitalized adults and children in serious condition. This produces the first favorable regulatory decision in the world for a specific indication against coronavirus.

"Although the known information on the safety and efficacy of remdesivir in hospitalized patients with the virus is limited, the investigational drug has been shown in a clinical trial to shorten the recovery time of some patients, " according to the official note from the agency. .

FDA emergency authorizations do not equate to full agency approval . To assess whether to issue one of these clearances, the agency assesses the available evidence and carefully studies the balance between any potential or known risks from untested products with any potential or known benefits from their use during an emergency.

This type of authorization responds to the statement of Alex Azar, US Secretary of Health and Human Services, stating that " there are circumstances that justify the emergency use of products or uses not yet approved, and in which the FDA can authorize their employment in an emergency situation to diagnose, treat, or prevent serious or life-threatening diseases caused by chemical, biological, radiological, and nuclear threats when adequate, approved, and available alternatives do not exist. "

The agency insists that "based on the criteria of this type of authorization and the available scientific evidence, it has been determined that it is reasonable to think that remdesivir can be effective in the treatment of Covid-19, and that, since there is no Appropriate, approved or available treatments, their known and potential benefits for treating this virus that compromises survival, currently outweigh the known and potential risks of using the drug. "

Express evaluation

The FDA emergency authorization comes just two days after the publication of promising data from the National Institutes of Health trial, in what the agency calls " a significant advance in the fight against Covid- 19 and yet another example of how the Trump Administration moves as quickly as possible in using life-saving science, "said Alex Azar.

The approval allows the drug to be distributed throughout the country and administered intravenously in seriously ill patients, that is, those with low blood oxygen levels or who need respiratory support with mechanical ventilation.

FDA Commissioner Stephen M. Hahn recalled that "there is enormous interest from all parties to identify and provide us with drugs to combat Covid-19, and through our Program for Acceleration of Treatments against Coronavirus , the FDA is working 24 hours and using all the tools at our disposal to accelerate these efforts. "

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