FDAは軽度から中等度の病気に対するモノクローナル抗体COVID-19療法を承認します

ソトロビマブは、SARS-CoV-2のスパイクタンパク質に対して特異的に向けられたモノクローナル抗体であり、ウイルスの付着とヒト細胞への侵入を阻止するように設計されています。. 臨床試験中, the treatment was shown to reduce hospitalization or death in COVID-19 patients by 85%. It was also shown to stand up against variants first reported in the U.K., South Africa, ブラジル, カリフォルニア, New York and India.

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With the authorization of this monoclonal antibody treatment, we are providing another option to help keep high-risk patients with COVID-19 out of the hospital,” Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, 前記. “It is important to expand the arsenal of monoclonal antibody therapies that are expected to retain activity against the circulating variants of COVID-19 in the United States.

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The EUA allows for the therapy to be distributed and administered as a 500-milligram single dose intravenously by health care providers. Potential side effects include anaphylaxis and infusion-related reactions such as rash and diarrhea.

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