Today, the U.S. Department of Health and Human Services (HHS) announced through a Federal Register filing that it granted two Emergency Use Authorizations (EUA) under the Food, Drug, and Cosmetic Act for biological products to be used during the COVID-19 pandemic. The EUA’s were given to GlaxoSmithKline LLC and Genentech, Inc. for the drugs Sotrovimab and Tocilizumab respectively.
According to the release, the Secretary of the HHS must certify that certain criteria have been fulfilled before authorizing a drug. The issuance of the EUA is dependent upon “a determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents … a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency … or a determination by the Secretary of HHS that there is a public health emergency, or a significant potential for a public health emergency” that could threaten national security.
The first EUA, granted to GlaxoSmithKline, which was effective as of May 26 2021, is for 500mg of the drug Sotrovimab. According to the document, “Sotrovimab is a recombinant human IgG1k monoclonal antibody that binds to a conserved epitope on the spike protein receptor binding domain of SARS-CoV-2” Based on 3 phases of a randomized, double blind, placebo-controlled clinical trial for this investigational drug, HHS determined that it was reasonable to believe that Sotrovimab may be effective in treating mild-to-moderate for adults and children. They further state that the drug should not be administered to those who are hospitalized or require oxygen therapy as a result of COVID-19.
The other EUA, which was attained by Genentech effective June 24, 2021, is for 200mg and 400mg Tocilizumab doses, also known by its commercial name Actemra. Actemra is described as a recombinant humanized monoclonal antibody that selectively binds to both soluble and membrane-bound human IL-6 receptors. Like the other drug, Actemra was approved after undergoing a randomized, double blind, placebo-controlled clinical trial. After completing these trials, doctors and scientists believe that Actemra can be used to treat adult and pediatric patients over the age of two who are suffering from COVID-19, the filing explained. According to the document, it should only be used on patients who are receiving systemic corticosteroids and require supplemental oxygen, invasive or non-invasive mechanical ventilation, or ECMO.
Collectively, both previously unapproved COVID-19 drugs treat a wide range of symptoms and severities related to the virus and will now be used to help those who could benefit most from it’s healing properties.