A monoclonal antibody treatment, bamlanivimab, gets emergency approval from FDA to fight the coronavirus

antibody treatment coronavirus
Photo via quapan/Flickr (CC BY 2.0)

Eli Lilly’s monoclonal antibody treatment to treat coronavirus patients, a drug called bamlanivimab, was granted emergency approval from the U.S. Food and Drug Administration on Nov. 9. The treatment is similar to the one administered to President Donald Trump when he was hospitalized with COVID-19 in October.

The FDA release noted that bamlanivimab is now authorized for patients with mild or moderate cases of COVID-19 who are at high risk of hospitalization or a severe case of the disease.

It has been “shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo,” the FDA wrote. However, it is not authorized for patients already hospitalized or who require oxygen therapy due to COVID-19—although Trump was hospitalized and reportedly required oxygen when he received his monoclonal antibody treatment.

“It’s a great day for science and medicine—sort of a feat of what’s possible,” Dr. Daniel M. Skovronsky, Eli Lilly’s chief scientific officer, told the New York Times. The article noted that “the emergency authorization for Eli Lilly raised immediate questions about who would get access to the treatment at a time when emergency authorizations for coronavirus vaccines might still be weeks or months away.” The company estimates that it can provide 1 million doses of the drug by the end of 2020.

However with at least 100,000 new daily coronavirus cases during the first week of November, it’s questionable whether Eli Lilly’s supply could meet the demand should current trends continue.

“There is a very real concern of inequitable distribution, unless we are very thoughtful about ensuring that facilities to administer the treatment are in disadvantaged communities,” Douglas White, a critical care physician and medical ethicist at the University of Pittsburgh School of Medicine, told the Washington Post. “We’ve already seen that testing centers for COVID are disproportionately in wealthier areas of towns and cities, and that introduces an inequity. If the same thing were to happen with treatment centers with the [monoclonal antibodies], it would be deeply ethically problematic.”

There are also logistical questions to contend with, as the drug requires lengthy intravenous infusions, and emergency rooms and clinics would have to factor in infection control measures for immunocompromised patients who might be in those facilities.

The Post reports that the U.S. government has already placed an order of 300,000 bamlanivimab doses, at a cost of $1,250 per dose.

Sources: FDA, New York Times, Washington Post

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