FDA Approves New COVID-19 Rx

FDA authorizes sotrovimab, a monoclonal antibody treatment for COVID-19

(RxWiki News) The US Food and Drug Administration (FDA) has given the thumbs-up to a new treatment for COVID-19.

It's a monoclonal antibody treatment called sotrovimab. The FDA approved it via an emergency use authorization (EUA) for those who are 12 years old or older.

This new treatment is meant for people who have mild to moderate COVID-19 and are at risk of the disease becoming serious. Those who are hospitalized or taking oxygen therapy for COVID-19 may not receive sotrovimab.

“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,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a press release. “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.”

Researchers make monoclonal antibodies like this newly approved drug in a lab. When they enter the body, they mimic your immune system's ability to fight off viruses and other harmful antigens.

In the case of sotrovimab, this antibody targets the distinctive "spike" protein on the COVID-19 virus. Attacking this spike protein helps prevent COVID-19 from entering your cells, the FDA noted.

The FDA approved this treatment via an EUA. That means that sotrovimab has not undergone the full FDA approval process at this time. Still, the FDA issued the EUA based on the results of a study of nearly 600 patients who had COVID-19 but were not hospitalized.

Roughly half of the patients received sotrovimab, and the other half received a placebo. Only 1 percent of the patients who received sotrovimab ended up going to the hospital for COVID-19, the FDA reported. For those who received the fake treatment, that rate was 7 percent.

Lab testing also suggested that sotrovimab was effective against the COVID-19 variants that were circulating at the time of publication.

The FDA approved sotrovimab for GlaxoSmithKline.

Never take any new medication without speaking with your doctor first. Ask your health care provider which COVID-19 treatment may be best for your case.