Remdesivir: The European Commission Approves this Drug for the Treatment of Severe Cases of COVID-19

Remdesivir – European Commission

Following the recommendation of the European Medicines Agency (EMA), the European Commission has authorized on Friday, July 3rd, the use of remdesivir to treat severe cases of COVID-19.

Recently, the EMA and its human medicines committee (CHMP) recommended the drug’s use in adults and adolescents of at least 12 yrs of age with severe cases of COVID-19.

Under this authorization, Veklury® (remdesivir) is indicated for the treatment of COVID-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg), with pneumonia requiring supplemental oxygen.

Remdesivir has been shown to speed up the recovery of coronavirus patients and is so far the only anti-COVID-19 medication to be given the green light in the European Union. “We will leave no stone unturned in our efforts to secure efficient treatments or vaccine against the coronavirus,” EU Health Commissioner Stella Kyriakides said in a press release.

The drug is developed by the American biopharmaceutical company Gilead Sciences, is a nucleotide analog, which inserts into viral RNA chains, causing their premature termination.

As we recently reported – remdesivir is the first antiviral treatment with proven efficacy against SARS-CoV-2 in an animal model of COVID-19. It was this National Institutes of Health (NIH) study using rhesus macaques, that the drug, when administered shortly before the peak of virus replication, resulted in significant clinical improvement, reduction in pulmonary infiltrates, and a reduction in pulmonary pathology.

In humans, in a recent double-blind, randomized, placebo-controlled trial, the drug was superior to the placebo in shortening the time to recovery in adults hospitalized with COVID-19 and with evidence of lower respiratory tract infection.

This New England Journal of Medicine study investigated the effects of a 10-day i.v. course of the, indicating that its benefit was seen in reducing the number of days to recovery (median, 11 days, vs 15 days), and in recovery according to the ordinal scale score at day 15.

Remdesivir has been approved as a treatment for patients with severe COVID-19 in Japan, Taiwan, India, Singapore, the United Arab Emirates and the European Union.

In the United States, the drug is authorized for use under an Emergency Use Authorization (EUA) only for the treatment of patients with suspected or laboratory-confirmed SARS-CoV-2 infection and severe COVID-19.

An Update

See: The new US antiviral program for pandemics

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