Remdesivir can only be administered to patients in a hospital or equivalent setting (Representative)
Washington:
The U.S. Food and Drug Administration on Thursday granted full approval to the antiviral drug remdesivir as a treatment for hospitalized patients with Covid-19, after conditional authorization was given in May.
Gilead said the drug, sold under the Veklury brand, was the only specific treatment for Covid-19 approved so far under a more rigorous process.
However, other treatments have been authorized for emergency use, although that approval may be revoked once the public health emergency caused by the coronavirus pandemic ends.
Other medications, such as the steroid dexamethasone, are also used in the fight against Covid-19.
Gilead’s shares on the New York Stock Exchange rose four percent shortly after the announcement.
“The FDA is committed to accelerating the development and availability of Covid-19 treatments during this unprecedented public health emergency,” said FDA Commissioner Stephen Hahn.
“Today’s approval is supported by data from multiple clinical trials that the agency has rigorously evaluated and represents a major scientific milestone in the Covid-19 pandemic.”
Europe and other countries such as Canada have also granted temporary approval for the use of remdesivir.
Remdesivir, which is given by injection, was one of the first drugs that showed relative promise in shortening recovery time in some coronavirus patients.
But its effectiveness in reducing the death rate is unproven.
It can be administered to adults and children over 12 years of age who weigh more than 40 kilos (88 pounds) who require hospitalization for the treatment of Covid-19, the disease caused by the new coronavirus.
The drug can only be administered to patients in a hospital or equivalent setting.
Emergency authorization has been granted for use in pediatric patients under 12 years of age weighing at least 3.5 kilos.
President Donald Trump, who tested positive for the coronavirus in early October, was treated with remdesivir at a military hospital outside Washington, among other drugs.
Faster recovery time
The drug was first developed to treat Ebola, a viral hemorrhagic fever.
In February, the US National Institute of Allergy and Infectious Diseases (NIAID) announced that it was dusting remdesivir to investigate against SARS-CoV-2, the pathogen that causes Covid-19, because it had shown promise in tests. with animals against other SARS coronaviruses. and MERS.
Their study involving more than 1,000 people, the results of which were published in April, found that patients taking the drug had a 31 percent faster recovery time than those taking a placebo.
Since the drug is complex to manufacture and is administered by injection, rather than a pill, there have been questions about whether the supply might initially be limited.
The United States gambled on remdesivir’s success from the start, rushing to reserve most of Gilead’s summer production.
Gilead has set the price at $ 390 per bottle in developed countries, or $ 2,340 for six bottles used during the normal five-day cycle, although private insurers in the United States will pay $ 520 per bottle.
(This story has not been edited by NDTV staff and is automatically generated from a syndicated feed.)
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