November 30, 2020

FDA Approves Veklury for COVID-19, Issues EUA for Bamlanivimab

In late October, the FDA approved the antiviral drug Veklury (remdesivir) for IV use as the first official treatment of COVID-19 requiring hospitalization.

This drug has been approved to treat patients 12 years of age and older, weighing at least 40 kilograms (88 pounds) and should only be administered in a hospital or healthcare setting capable of providing acute care comparable to inpatient hospital care.

This approval does not authorize use across other populations covered in a previous Emergency Use Authorization (EUA) issued back in May.

The approved drug label includes dosing recommendations for patients on and off ventilators, and Veklury is not recommended for patients with renal impairment. The FDA notes that all patients, prior to receiving Veklury and during such treatment, should receive renal and hepatic laboratory testing, as Veklury may increase levels of liver enzymes.

Potential side effects include liver injury and allergic reactions, which can consist of changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling, rash, nausea, sweating, or shivering.

Veklury should not be taken with chloroquine phosphate or hydroxychloroquine sulfate, as such combined use can reduce antiviral activity.

Later in November, the FDA issued an emergency use authorization (EUA) to bamlanivimab for the treatment of mild-to-moderate COVID-19.

Bamlanivimab is an investigational monoclonal antibody; monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses. Bamlanivimab 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.

An EUA is not an FDA approval; an EUA is a declaration that circumstances exist to justify the emergency use of drugs and biological products that have not been FDA-approved, particularly when no other effective alternatives are available, assuming the benefits appear to outweigh the risks.

Bamlanivimab is authorized for COVID-19 patients who are 12 years of age and older, weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions. Bamlanivimab is administered intravenously as a single dose by a health care provider.

While the safety and effectiveness of bamlanivimab continues to be evaluated, bamlanivimab was 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.

Bamlanivimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.

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