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FDA Grants Emergency Use to Two New COVID Treatments

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Feb. 10, 2021 -- The FDA has granted emergency use authorization to two new combination treatments for mild-to-moderate COVID-19 in people 12 years and older.

Bamlanivimab and etesevimab (both from Eli Lilly) are authorized to treat people with elevated risk for severe disease, including adults over 65 and those with relevant comorbidities.

The authorization is based in part on the BLAZE-1 pre-clinical study of 1035 people with mild-to-moderate COVID-19 symptoms. A single infusion of the combined monoclonal antibodies significantly reduced hospitalization and death rates by about 70% compared to placebo.

A total 11, or 2%, of people treated with the combined therapy were hospitalized, compared to 36 or 7% of the placebo group. Ten participants died during the study, all in the placebo arm.

The therapy is not intended to treat people already hospitalized with COVID-19. The treatment has not been adequately studied in this patient population, the FDA said in a news release. Furthermore, evidence suggests monoclonal antibodies can worsen outcomes for people hospitalized with COVID-19 who require high-flow oxygen or mechanical ventilation.

"The data supporting this emergency authorization add to emerging evidence that points to the clinical utility of neutralizing antibodies for the treatment of COVID-19 in certain patients,” Patrizia Cavazzoni, MD, acting director of the FDA's Center for Drug Evaluation and Research, said in the release. "As part of our Coronavirus Treatment Acceleration Program, the FDA uses every resource at our disposal to make treatments such as these monoclonal antibodies available while continuing to study their safety and effectiveness."

This EUA announcement Feb. 9 gives doctors additional monoclonal antibody treatment options. Bamlanivimab received emergency authorization as monotherapy in November, as did another combination of monoclonal antibodies from Regeneron.

Bamlanivimab and etesevimab each target different components of the SARS-CoV-2 spike protein. They are designed to block the ability of virus to attach and enter human cells. The therapy should be administered as soon as possible following a positive COVID-19 test, and within 10 days of symptom onset, according to a Lilly news release.

The EUA comes with a fact sheet from the FDA that outlines dosing instructions, potential side effects, and drug interactions. Possible side effects of bamlanivimab and etesevimab administered together include nausea, dizziness, pruritus, and rash.

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