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Another monoclonal antibody treatment has received emergency authorization from the U.S. Food and Drug Administration to treat patients with severe illness and high-risk hospitalization for COVID-19.
Monoclonal antibodies are proteins made in the laboratory to replicate the immune system’s ability to resist viruses.
The new drug sotrovimab was jointly developed by GlaxoSmithKline and Vir Biotechnology Inc. Studies have shown that it is not only effective against the variants of the coronavirus that caused great damage in India, but also against the variants originally discovered in the United Kingdom and the southern part of the United Kingdom. Africa, Brazil, California and New York.
Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in an interview: “Through the authorization of this monoclonal antibody therapy, we provide another option to help keep high-risk COVID-19 patients out.” statement.
“It is important to expand the library of monoclonal antibody therapies that are expected to remain active against circulating variants of COVID-19 in the United States.”
Antibody therapy from Eli Lilly and Company with Regenerating element It has been approved, but the Eli Lilly antibody mixture has been found to be less effective against the South African and Brazilian variants.
This latest antibody therapy is a single drug, not a mixture of antibodies. Its authorization is based on a study of 583 volunteers who recently started showing symptoms of COVID-19 within the last 5 days. Compared with placebo-treated participants, study participants who received sotuzumab had an 85% lower risk of hospitalization or death.
So far, the antibody mix from Eli Lilly and Regeneron has not been fully utilized during the pandemic. Allegedly, the logistics of treatment, lack of knowledge and confidence in antibody mixtures have become part of the problem. U.S. News and World Report.
Sotuzumab Research is being carried out in ongoing clinical trials. It is expected that in the first half of 2021, the safety and efficacy data of all populations from the COMET-ICE trial on the 29th day will be analyzed.
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