FDA Issues Emergency Use Authorization for Bamlanivimab

By Jonathan Springston, Editor, Relias Media

The FDA this week issued another emergency use authorization (EUA) for a COVID-19 therapeutic, bamlanivimab.

The agency’s order allows this investigational monoclonal antibody to be administered to patients age 12 years and older who weigh at least 40 kg, have tested positive for SARS-CoV-2, are showing mild to moderate symptoms, and are at serious risk for showing severe symptoms or becoming hospitalized.

“The FDA’s emergency authorization of bamlanivimab provides healthcare professionals on the frontline of this pandemic with another potential tool in treating COVID-19 patients,” Patrizia Cavazzoni, MD, acting director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “We will continue to evaluate new data on the safety and efficacy of bamlanivimab as they become available.”

In two randomized, double-blind, placebo-controlled clinical trials that are in Phase II, investigators found bamlanivimab reduced COVID-19-related ED visits or hospitalization for patients at serious risk for disease progression within 28 days after treatment vs. placebo. Notably, this drug has yet to demonstrate efficacy for patients already hospitalized with COVID-19.

Because trials are ongoing, the FDA has not issued full approval for bamlanivimab. However, the agency will issue an EUA for a drug after carefully studying the data and weighing risks and benefits. An EUA carries several caveats designed to narrow the list of potential patients to those who will benefit the most while protecting many others from any potential adverse effects.

Since the COVID-19 pandemic began, the FDA has issued a few EUAs for different therapeutics. In a statement released Thursday, the Infectious Diseases Society of America (IDSA) said it is grateful for the “urgency in expanding therapeutic options for COVID-19.”

“We strongly urge for clinical trials to continue and for close ongoing data monitoring and reporting on the patients receiving bamlanivimab under the EUA so that we can determine its safety and efficacy,” the group wrote.

IDSA also expressed concern about the “current scarcity of the drug and the logistics required for administering it.” To ensure all patients who need it can access the drug, the group recommended federal officials boost monitoring programs and strengthen capacity in delivery systems.

Sometimes, drugs may graduate from an EUA to a more formal FDA approval. For example, the agency issued an EUA for remdesivir in May. Clinicians could use the drug in young patients hospitalized with COVID-19. In late October, the FDA issued an approval for remdesivir (trade name Veklury) to treat COVID-19 that requires hospitalization in patients 12 years of age and older. Be sure to check out the upcoming November 30 issue of Internal Medicine Alert to read more about Veklury.

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