Tuesday, November 10, 2020

FDA approves emergency-use of COVID-19 antibody treatment

Some good news came yesterday evening in the ongoing fight against the coronavirus: The Food & Drug Administration granted emergency-use authorization to a new drug from Eli Lilly intended to treat those with mild COVID-19 symptoms.

The drug is a monoclonal (i.e. lab-created) antibody designed to mimic the way the immune system attacks the coronavirus and instigate an aggressive immune-system response to continue fighting the virus. The drug is intended to help prevent patients with mild infections from developing more-severe symptoms or advanced cases of the disease.

“Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses,” the FDA said in a statement. “Bamlanivimab is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells.”

According to the Washington Post coverage, health experts are hoping that the drug will serve “as a bridge to a vaccine,” meaning that its use will enable doctors to successfully treat a greater number of COVID-19 patients before a working vaccine is made available.

“Bamlanivimab, when given early in the disease course, may help patients clear the virus and reduce covid-related hospitalizations, supporting our belief that neutralizing antibodies can be an important therapeutic option for patients fighting this virus,” Eli Lilly’s chief scientific officer said in a statement.

The drug, called bamlanivimab, must be administered to patients intravenously in a hospital or clinic during the early onset of the virus. This is the first monoclonal antibody that the FDA has authorized for treating COVID-19. Though its introduction is a cause for celebration, its distribution will be somewhat limited at least until the drug company can increase its production. Eli Lilly estimates that it can make available 1 million doses by the end of 2020, and the U.S. has already negotiated to obtain 300,000 of them.

“Government health officials said they will allocate those doses, free of charge, following a strategy similar to what is used for remdesivir, an antiviral drug administered to hospitalized patients,” the Post reports. “Each state will receive an allotment based on an algorithm that evaluates confirmed coronavirus cases over the previous week. Then the states will select administration sites, and wholesaler AmerisourceBergen will distribute the drug, probably for use in emergency rooms or special clinics.”

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