FDA Grants an EUA for Bamlanivimab to Treat COVID-19 Patients Who Meet Certain Criteria

On November 9, 2020, the U.S. Food and Drug Administration (FDA) granted Eli Lilly and Company an emergency use authorization (EUA) for bamlanivimab to treat mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab, says an FDA press release “is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells.” Based on the outcomes from a phase two randomized, double-blind, placebo-controlled clinical trial, the agency believes the drug shows promise for effectively treating certain COVID-19 positive patients.

In a letter to Eli Lilly and Company, the FDA notes that patients who receive bamlanivimab must meet the following criteria:

• test positive for SARS-CoV-2;
• present with mild to moderate COVID-19;
• be 12 years of age and older;
• weigh at least 40 kg; and
• be in an outpatient setting but at high risk for progressing to severe COVID-19 and/or hospitalization.

Furthermore, the FDA advises healthcare providers who administer the medication to note the following:

• bamlanivimab must be administered intravenously, as a single dose and in a healthcare setting with immediate access to treatment for a severe infusion reaction and the ability to activate the emergency medical system; and
• cannot be given to patients who are hospitalized with COVID-19 or require oxygen therapy due to COVID-19.

Additionally, physicians must provide patients prescribed bamlanivimab with a fact sheet outlining important information pertaining to dosing instructions, potential side effects and drug interactions.

Acting Director of the FDA’s Center for Drug Evaluation and Research Patrizia Cavazzoni explains the EUA “provides health care professionals on the frontline of this pandemic with another potential tool in treating COVID-19 patients.” The agency says it will continue to evaluate and communicate new information on the safety and efficacy as it becomes available.

MLMIC has assembled a number of critical resources to support New York physicians as they care for patients during the pandemic, including:

• Prediction Tools to Manage and Treat COVID-19, a blog post on COVID-19 prediction models designed to inform physicians, health systems and health officials as they care for patients with the virus;

• FDA Approves Veklury for Treatment of COVID-19 Patients Who Meet Certain Criteria, a blog post on the FDA approval of Veklury for treating infected patients who are hospitalized, 12 years of age and older and weigh at least 40 kilograms;
• NIHR Identifies Four Syndromes Commonly Experienced by Patients With “Long COVID,” a blog post on four common syndromes impacting patients with ‘long COVID;” and
• Study Says Improved Treatment for COVID-19 is Reducing Mortality Rates, a blog post on the decline in the number of deaths among hospitalized COVID-19 patients.