USA – Gilead Sciences announced that its antiviral medicine Veklury (remdesivir) has been granted expedited approval for the treatment of non-hospitalized adult and adolescent patients with mild-to-moderate COVID-19 who are at high risk of progression to severe disease, including hospitalization or death.

The Food and Drug Administration said the intravenous treatment, which had previously only been available to hospital patients, could now be given to outpatients with mild-to-moderate illness.

Remdesivir, a coronavirus treatment manufactured by Gilead Sciences, was one of the first coronavirus treatments approved in 2020.

Later that year, the drug received full FDA approval for people aged 12 and up. An emergency use authorization allows for treatment of younger children, but the latest outpatient expansion includes both age groups.

Physicians scrambling to keep covid patients out of the hospital as waves of infections crowd medical facilities welcomed the FDA action.

Two of the three authorized monoclonal antibody treatments are ineffective against omicron; there are shortages of the one antibody drug that still works; and demand for recently cleared antiviral pills far outstrips supply.

The FDA action on Friday followed the publication of a study in the New England Journal of Medicine that found remdesivir can be beneficial when administered as an outpatient.

The drug reduced hospitalization and death by 87 percent when given soon after a coronavirus diagnosis, according to the study, when compared to patients who did not receive the drug.

The study’s findings are based on research that predates the delta variant, which spread quickly during the summer, and omicron, which now accounts for more than 95 percent of coronavirus cases in the United States.

However, researchers believe remdesivir will continue to be effective even if omicron develops resistance to some monoclonal antibody therapies.

The findings were based on a Gilead-sponsored study that included 562 unvaccinated coronavirus patients who were randomly assigned to receive the three-day infusion therapy or a placebo from September 2020 to April 2021.

All of the participants were at high risk for developing a severe case because they were 60 or older, or had at least one other condition that makes the coronavirus more dangerous, such as high blood pressure, cardiovascular disease, diabetes or obesity.

The FDA said in a statement that the treatment is not a replacement for vaccines, which continue to provide the most effective protection against coronavirus.

On the heels of the FDA’s recent authorization of two oral antiviral drugs, [the latest] actions bolster the arsenal of therapeutics to treat COVID-19 and respond to the surge of the Omicron variant,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.

NIH’s updated treatment guidelines

The National Institutes of Health updated treatment guidelines for outpatients with mild-to-moderate covid earlier this week, encouraging the use of remdesivir while noting that the FDA had not yet approved it for those patients.

The guidelines also recommend using sotrovimab, a monoclonal antibody that is effective against omicron.

This medication is administered as a single intravenous infusion as soon as possible after the onset of symptoms and within 10 days of the onset of symptoms. GlaxoSmithKline and Vir Biotechnology created it.

Two newly approved coronavirus treatments are also recommended: one by Pfizer and the other by Merck and its partner, Ridgeback Biotherapeutics. However, oral medications such as sotrovimab are in short supply.

The guidelines advised against using two of the three monoclonal antibody treatments approved for early stage coronavirus because they are unlikely to work against the omicron variant.

Monoclonal antibody therapies from Regeneron Pharmaceuticals and Eli Lilly, according to the guidelines, “are predicted to have markedly reduced activities” against omicron.

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