The United States Medicines Agency (FDA) on Thursday granted permanent authorization to the antiviral drug remdesivir for hospital patients with Covid-19, confirming the conditional authorization granted in May.
The Gilead laboratory, which manufactures the product, saw its stock on the New York Stock Exchange jump 4% shortly after the announcement.
Gilead said it had received authorization for the drug, under the brand Veklury, stressing that it was the only specific treatment against Covid-19 thus authorized after a more rigorous and definitive verification procedure.
An emergency authorization is temporary, given on the basis of less complete data than for a full authorization, and it can be revoked at the end of the state of health emergency.
Other treatments have been available for months in hospitals thanks to temporary authorizations or because they are drugs formerly authorized for other diseases, such as the corticosteroid
dexamethasone
.
Europe and other countries have also temporarily authorized remdesivir since the spring.
The treatment Trump received
Remdesivir, initially unsuccessfully developed against Ebola hemorrhagic fever, was one of the first drugs to demonstrate relative effectiveness in rigorous trials in shortening the recovery time of patients hospitalized with the coronavirus by several days.
But it hasn't been shown to reduce mortality, unlike dexamethasone.
Veklury may be given, by injection, to adults and children over 12 years of age weighing 40 kg or more, in cases requiring hospitalization.
It can only be administered in a hospital or in an equivalent environment.
At the same time, an emergency authorization was granted for children under 12 weighing at least 3.5 kg.
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This is one of the treatments that the US government bet on early, pre-purchasing almost all of the production from July to September by summer.
US President Donald Trump, who fell ill with Covid-19 in early October, himself received the treatment for five days, among other drugs.
The price had been set by Gilead at 390 dollars per vial in all developed countries, or 2340 dollars for a normal treatment of six vials in five days (520 dollars per vial in the United States via private insurance).
For developing countries, Gilead has contracted royalty-free licenses to generic drug manufacturers in India, Pakistan and Egypt.
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The European Union, where remdesivir received conditional marketing authorization in July, ordered 500,000 doses in early October.