Tag Archives: Sotrovimab

Health

The Latest on Sotrovimab and Bebtelovimab COVID-19 Treatments

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A new report from CNET provides the latest on available monoclonal antibody treatments. With Ba.2 or “stealth omicron” accounting for more than 70% of COVID cases in the U.S., it helps to have the latest information on these potentially life-saving treatments.

From CNET…

In March, GlaxoSmithKline said the FDA found that its treatment sotrovimab“unlikely” to be effective against the BA.2 variant. The companies added that they are preparing data on a higher dose of sotrovimab that may work against BA.2.

Sotrovimab, like other monoclonal antibodies, has been used as treatment for COVID-19 in people most at risk for severe COVID-19 disease or hospitalization in the early days of their symptoms.

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Bebtelovimab, made by Eli Lilly, is a monoclonal antibody still authorized for use in patients 12 and up who have mild or moderate COVID-19 and are at high risk for severe disease. The antibody should be used when other treatments for high-risk patients are either unavailable or inappropriate, and given within the first seven days of COVID-19 symptoms, the FDA said. 

According to the FDA, “Bebtelovimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19.”

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World

WHO recommends two new drugs to combat COVID-19 infection

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The World Health Organization (WHO) recommended two new drugs to combat COVID-19 infections.

The first new drug that is recommended for critical COVID-19 cases is baricitinib, an oral drug that suppresses the immune system when overstimulated. 

The WHO recommends baricitinib is given with corticosteroids.

The second drug which should be used for mild cases where a person has a high chance of hospitalization is sotrovimab, a monoclonal antibody drug. 

This should be given to individuals who are unvaccinated, older, have a compromised immune system or are obese, according to the WHO. 

“The extent to which these medicines will save lives depends on how widely available and affordable they will be,” the WHO said in its statement. 

The recommendations come as concerns arise that existing COVID-19 treatments will not be effective against the omicron variant.

The two drugs were also invited on Friday to go through the WHO’s Prequalification Unit, which “assesses the quality, efficacy and safety of priority health products to increase access in lower income countries.”

The WHO recommended the two drugs after evaluating evidence gathered in seven trials examining 4,000 mild, severe and critical COVID-19 cases.

The Food and Drug Administration has already approved baricitinib and sotrovimab for emergency use. 

The WHO has recommended against ruxolitinib and tofacitinib due to their uncertain effects.



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Business

Texas runs out of monoclonal antibody treatment effective against omicron

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Texas has run out of its supply of monoclonal antibodies, and infusion centers in the state will be unable to offer the treatment until more shipments are sent out in January.

Infusion centers in Austin, El Paso, Fort Worth, San Antonio and The Woodlands have all gone through their supply of sotrovimab, the only antibody treatment believed to be effective against the omicron variant, the Texas Health and Human Services Commission said on Monday.

The agency said infusion centers in Texas will be unable to offer the treatment until “federal authorities ship additional courses of sotrovimab to Texas in January.”

“Other monoclonal antibodies have not shown to be effective against the Omicron variant, which now accounts for more than 90 percent of new cases. The infusion centers will continue to offer those antibodies as prescribed by health care providers for people diagnosed with a non-Omicron case of COVID-19,” the Texas commission said.

A “limited supply” of the recently approved oral antiviral drugs — one from Merck and Ridgeback Biotherapeutics and the other from Pfizer — will soon be available in Texas, the agency added, noting that the supply of these drugs is also regulated by the federal government.

Health officials began stockpiling doses of sotrovimab this month after studies showed that it was effective against the highly transmissible omicron variant.

On Dec. 17, the U.S. Department of Health and Human Services (HHS) released distribution determinations for sotrovimab, allocating 2,694 doses for Texas. The department said at the time that the government’s supply of the antibody treatment was “extremely limited” and additional units would not be available until the week of Jan. 3.

HHS recommended reserving sotrovimab for use in the highest risk outpatients, including patients over the age of 65 and those who are immunocompromised.



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