Ozarks Healthcare Monoclonal Antibody Infusion for the Treatment of COVID-19.

On November 30, 2020, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Bamlanivimab, manufactured by Eli Lilly, and for Casirivimab + Imdevimab, manufactured by Regeneron (two medications given together) for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19. This includes those who are 65 years of age or older or who have certain chronic medical conditions.

Why is the Monoclonal Antibody treatment available now?

Bamlanivimab and Casirivimab + Imdevimab have not yet undergone the same type of review as an FDA-approved or cleared product. FDA may issue an "emergency use authorization" when certain criteria are met, which includes that there are no adequate, approved, and available alternatives. In addition, the FDA decision is based on the totality of the scientific evidence available showing that the product may be effective in treating COVID-19 during the COVID-19 pandemic and that the known and potential benefits of the product outweigh the known and potential risks of the product.

How is the Monoclonal Antibody treatment given?

Both Bamlanivimab, manufactured by Eli Lilly, and Casirivimab + Imdevimab, manufactured by Regeneron (two medications are given together) are given as a single infusion over one hour. If your provider determines that you meet the criteria to receive a monoclonal antibody treatment for the treatment of the coronavirus disease 2019 (COVID-19), you will be referred to the infusion center at Ozarks Healthcare.

Your provider will review the risks, benefits, alternatives, and limitations of these treatments with you. These treatments are currently unapproved drugs authorized for use under the Emergency Use Authorization by the U.S. Food and Drug Administration (FDA). You will receive paperwork explaining known factual information about each treatment. Please review both carefully, as which treatment you may receive could depend on current availability. These medications must be given within 10 days, preferably less than 72 hours, of onset of COVID-19 symptoms. A positive COVID-19 test result is also one of the criteria that must be met before either treatment can be administered.

Download: Patient treatment information

Download: Fact Sheet for Bamlanivimab

Download: Fact Sheet for Casirivimab + Imdevimab

What is an Emergency Use Authorization (EUA)?

Under section 564 of the Federal Food, Drug & Cosmetic Act, the FDA may, pursuant to a determination and declaration by the HHS Secretary, authorize an unapproved product or unapproved uses of an approved product for emergency use.

Emergency use authorization is NOT the same as FDA approval or licensure.

Download: FDA: Frequently Asked Questions on the Emergency Use Authorization of Bamlanivimab

Download: FDA: Frequently Asked Questions on the Emergency Use Authorization of Casirivimab + Imdevimab