Gilead’s remdesivir first to win USA approval to treat COVID-19

24 Octobre, 2020, 15:20 | Auteur: Auguste Feret
  • FDA Approves Remdesivir for Certain Patients With COVID-19

Remdesivir, which will be sold under the brand name Veklury, costs US$3,120 for a five-day treatment course, or US$2,340 for government purchasers such as the Department of Veterans Affairs. While the data did not find a statistically significant benefit in reducing mortality, doctors involved in one of the studies, published in the New England Journal of Medicine (NEJM), reported a trend toward reduced mortality after about a month, especially among people who received the drug early in their infection, as Kalil notes.

The Food and Drug Administration has officially approved Gilead Sciences' antiviral drug remdesivir for use in treatment of coronavirus, according to Fox Business.

The approval is based on a United States government-sponsored trial involving more than 1,000 hospitalised coronavirus patients that found that those who received the drug recovered about five days faster than those who were given a placebo.

"Today's approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the Covid-19 pandemic", said FDA Commissioner Stephen Hahn.

Remdesivir, like other repurposed drugs, had been administered to patients across the world on the basis of emergency use approvals by regulators in various countries, including India.

Explained: What does FDA's approval of remdesivir as the first drug to treat coronavirus mean?

Its study involving more than 1,000 people, the results of which were released in April, found that patients on the drug had a 31 percent faster time to recovery than those on a placebo.

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The drug did not go through an outside panel of experts, called an advisory committee, before being approved.

"The FDA tends to pick for advisory committees those drugs that are most novel and those that present safety issues, and those that are close calls with respect to effectiveness", Lurie said. This is not some massive breakthrough.

Thursday's approval did not cover the entire population that was covered under the agency's emergency authorization in May.

The World Health Organization has repeated that the antiviral drug remdesivir appears to have little or no effect as a treatment for COVID-19.

One of the studies showed that that "the median time to recovery from Covid-19 was 10 days for the Veklury group compared to 15 days for the placebo group".

Gilead's shares on the New York Stock Exchange jumped four percent soon after the announcement. Other medications and treatment strategies, such as anti-inflammatories and keeping patients on their stomachs to prevent worsening respiratory symptoms, are other likely contributors to the decline in death rates.

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