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FDA Issues Third COVID-19 Therapeutic EUA This Month

By Jonathan Springston, Editor, Relias Media

The FDA has issued an emergency use authorization (EUA) for a dual COVID-19 therapeutic (casirivimab and imdevimab), the third such EUA awarded this month.

Clinicians should administer casirivimab and imdevimab together to adult and pediatric patients (age ≥ 12 years and weight at least 40 kg) with positive results of direct SARS-CoV-2 viral testing and mild to moderate COVID-19 symptoms. These eligible patients also would be at high risk (i.e., age ≥ 65 years or those with certain chronic medical conditions) for developing severe COVID-19 symptoms.

Following a familiar pattern, the agency based this latest authorization on data from a recent study — in this case, a randomized, placebo-controlled, double-blind, clinical trial that included 799 nonhospitalized adults with mild to moderate COVID-19 symptoms. Of these patients, 266 received a single intravenous infusion of 2,400 mg casirivimab and imdevimab (1,200 mg of each), 267 received 8,000 mg casirivimab and imdevimab (4,000 mg of each), and 266 received a placebo within three days of testing positive for SARS-CoV-2.

Surprisingly, it was a secondary endpoint that attracted the agency’s attention: a decline in hospitalization and emergency department visits within 28 days of treatment. For patients at high risk for disease progression, hospitalizations and emergency department visits occurred in 3% of casirivimab and imdevimab-treated patients, on average, vs. 9% of placebo patients.

With this latest approval, the FDA has now issued an EUA for eight different COVID-19 therapeutics since the pandemic began in March. 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 read the November 30 issue of Internal Medicine Alert to learn more about Veklury.

Bamlanivimab was the first therapeutic to receive an EUA this month. The upcoming December 15 issue of Internal Medicine Alert will include a detailed analysis of this drug and the research behind it that led to the FDA’s authorization. For more Relias Media coverage of the COVID-19 pandemic, please click here.