FDA Approves Emergency Use of Eli Lilly's COVID-19 Antibody Treatment
The monoclonal antibody treatment is called bamlanivimab, and is meant for patients over 12 years old with mild to moderate forms of COVID-19, but who have underlying issues that could lead to worse conditions.
These issues include diabetes, sickle cell disease, chronic kidney disease, and obesity.
Expansion of doctor use
The FDA's emergency approval allows doctors to use Eli Lilly's monoclonal antibody treatment, something that was previously limited to clinical trials of the drug.
The hope with Eli Lilly's new treatment is to prevent people from requiring hospitalization and keeping the hospitals from being over-capacity.
"The FDA’s emergency authorization of bamlanivimab provides health care professionals on the frontline of this pandemic with another potential tool in treating COVID-19 patients," said Patrizia Cavazzoni M.D., acting director of the FDA’s Center for Drug Evaluation and Research.
The FDA's statement said that the safety and effectiveness of this new drug are still being evaluated, however, during its clinical trials bamlanivimab reduced COVID-19 related hospitalizations successfully.
Today’s emergency use authorization for Lilly’s investigational #COVID19 antibody is a key moment in the fight against this disease. There’s more work to be done, but we’re proud of this contribution to the global effort to beat COVID-19. pic.twitter.com/xshy8X8hFD— Eli Lilly and Company (@LillyPad) November 10, 2020
The treatment is not to be used on already hospitalized patients who require oxygen therapy, though, which may lead to worse clinical outcomes if monoclonal antibodies such as bamlanivimab are administered.
Monoclonal antibodies are created in a lab environment and copy the body's natural antibodies. These antibodies act by recognizing specific pathogens, such as SARS-CoV-2, and alert the immune system to fight them off.
During its second phase of clinical trials, the research concluded that the drug was not any better than a placebo, however, it did minimize the need for hospitalization later down the line.
Administered through an IV, bamlanivimab is given in just one dose. The FDA highlights potential side effects as a result of taking the drug, which include nausea, diarrhea, dizziness, headaches, itching, and vomiting.
Eli Lilly has already begun manufacturing the drug, and the plan is to have one million doses available before the end of the year.