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Tags: who | covid-19 | drugs | fda | eua | emergency | use

WHO Recommends Two COVID-19 Treatment Drugs

bruce aylward speaking at a world health organization news conference with chinese writings on his placard

By    |   Saturday, 15 January 2022 01:27 PM

The World Health Organization on Friday recommended two drugs to treat COVID-19.

The organization announced it was recommending baricitinib, a drug used to treat rheumatoid arthritis for patients with severe or "critical" COVID-19 disease, and sotrovimab, a monoclonal antibody, for patients with mild or moderate disease.

According to Medscape, baricitinib is a usually prescribed by doctors in a 2-milligram tablet used for adults with moderate to severe rheumatoid arthritis and was approved as an emergency use authorization by the Food and Drug Administration on Nov. 19, 2020, with a 4-milligram dose for COVID-19 patients that were hospitalized and required supplemental oxygen, ventilation or "extracorporeal membrane oxygenation."

"Today's action demonstrates the FDA's steadfast efforts to make potential COVID-19 treatments available in a timely manner, where appropriate, while continuing to support research to further evaluate whether they are safe and effective," FDA Commissioner Stephen M. Hahn, M.D. said at the time of the approval. "As part of our Coronavirus Treatment Acceleration Program, the FDA continues to use every possible avenue to facilitate new treatments for patients as quickly as possible to combat COVID-19."

The FDA has also approved the unapproved drug sotrovimab for EUA use in adults and pediatric patients over the age of 12 who have a high risk to progress to more severe COVID-19 disease, including hospitalization and death, according to the agency.

The drug is specifically meant for older patients with conditions like diabetes, hypertension, obesity, and those who have not been vaccinated, and is an alternative to the monoclonal antibody "cocktail" of casirivimab and imdevimab, according to the WHO.

It is the eighth recommendation by the organization's guidelines, based on evidence from seven trials involving more than 4,000 patients with COVID-19, and ranging in severity from mild, to severe, to critical disease, the WHO added.

While it recommends these medications to treat the disease, it also turned away two other drugs, ruxolitnib, and tofacitinib, for use with severely-ill COVID-19 patients "given their uncertain effects," it concluded.

Despite the recommendation by the WHO, a December article in Nature found sotrovimab needs to have three times the concentration to be effective against omicron as it does for other previous variants.

Stuart Turville, a virologist at the Kirby Institute in Sydney, Australia, told Nature the drop in effectiveness from the drug was not like it was for other monoclonal antibody treatments that became much less effective against the omicron variant.

"It's nothing like what we saw for the others," he told the publication in December.

The U.S. Department of Health and Human Services said in a Dec. 17, 2021, update, that it was "actively preparing" 55,000 doses of sotrovimab for "immediate allocation" to jurisdictions, which were expected to see the medicine "soon."

According to the agency, the doses will be allocated to regions based on COVID-19 incidence rates and hospitalizations.

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The World Health Organization on Friday recommended two drugs to treat COVID-19.
who, covid-19, drugs, fda, eua, emergency, use, authorization, therapeutics, treatments
Saturday, 15 January 2022 01:27 PM
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