FDA Approves New COVID-19 Treatment Leave a comment


(RxWiki News) The US Food and Drug Administration (FDA) has approved a new treatment for COVID-19.

The FDA approved the monoclonal antibodies bamlanivimab and etesevimab to be given together to patients who have mild to moderate COVID-19. This treatment was approved for use in patients who are 12 years old or older.

This approval comes via emergency use authorization (EUA). The FDA grants an EUA to a drug or device that needs to be approved quickly in light of a public health emergency.

“The data supporting this emergency authorization add to emerging evidence that points to the clinical utility of neutralizing antibodies for the treatment of COVID-19 in certain patients,” said Dr. Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research, in a press release. “As part of our Coronavirus Treatment Acceleration Program, the FDA uses every resource at our disposal to make treatments such as these monoclonal antibodies available while continuing to study their safety and effectiveness.”

Monoclonal antibodies like bamlanivimab and etesevimab are proteins made in a laboratory. They mimic the immune system in order to combat pathogens like viruses, according to the FDA. Bamlanivimab and etesevimab target a particular part of the virus that causes COVID-19. This is meant to prevent the virus from attaching to or entering human cells.

The FDA issued the EUA for bamlanivimab and etesevimab based on data from a clinical trial of more than 1,000 adults with COVID-19. These adults were not hospitalized. Among patients who received a placebo, 7 percent ended up going to the hospital or dying. For patients who received the monoclonal antibodies, only 2 percent were hospitalized. And none died.

The FDA noted that this new treatment is not approved for patients who are hospitalized or receiving oxygen therapy due to COVID-19. Monoclonal antibodies have not been studied in these settings. And they may be tied to worse outcomes for hospitalized patients who require ventilation or high oxygen flow.

This EUA was issued to Eli Lilly and Co.

If you are diagnosed with COVID-19, talk to your health care provider about the best treatment for your unique case.


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