Arlington, VA—The Infectious Disease Society of America (IDSA) has updated its guidelines on the treatment and management of COVID-19 patients to reflect changes with several medications previously under emergency authorization by the FDA.
The IDSA points out that as of earlier this year, “fewer than 10% of circulating variants in the U.S. are susceptible to tixagevimab/cilgavimab (Evusheld), the sole product that has been available for pre-exposure prophylaxis. Tixagevimab/cilgavimab is therefore no longer authorized for use in the U.S.”
The FDA revised the EUA for Evusheld in late January to limit its use to when the combined frequency of nonsusceptible SARS-CoV-2 variants nationally is less than or equal to 90%. Based on that revision, Evusheld is not currently authorized for use in the United States until further notice.
“Data show Evusheld is unlikely to be active against certain SARS-CoV-2 variants”, the FDA pointed out, adding, “Today’s action to limit the use of Evusheld prevents exposing patients to possible side effects of Evusheld such as allergic reactions, which can be potentially serious, at a time when fewer than 10% of circulating variants in the U.S. causing infection are susceptible to the product.”
The agency explained, “Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses, like SARS-CoV-2. And like other viruses, SARS-CoV-2 can mutate over time, resulting in certain products not working against certain variants. This is the case with Evusheld and prompted the changes to the authorization that FDA is making today.”
Instead, Paxlovid (nirmatrelvir/ritonavir), Veklury (remdesivir), and Lagevrio (molnupiravir) are recommended for certain patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death. Healthcare providers should assess whether treatments are right for their patients.
Pharmacists should be aware that the government recommends facilities and providers with Evusheld retain all product in case SARS-CoV-2 variants, which are neutralized by Evusheld, become more prevalent in the U.S. in the future.
Evusheld is not the only product affected, however. The IDSA no longer recommends neutralizing antibodies for postexposure prophylaxis. “The first two U.S. FDA authorized anti-SARS-CoV-2 neutralizing antibody combinations, bamlanivimab/etesevimab and casirivimab/imdevimab, were found to be largely inactive against the Omicron BA.1 and BA.2 variants, rendering these products no longer useful for either treatment or post-exposure prophylaxis,” the association explained. “As a result, Emergency Use Authorization was withdrawn by the U.S. FDA for both bamlanivimab/etesevimab and casirivimab/imdevimab, leaving no available neutralizing antibody product for use in the United States for postexposure prophylaxis.”
At the end of November, the FDA also withdrew the EUA for bebtelovimab, the one anti–SARS-CoV-2 neutralizing antibody product that had retained in vitro activity against most previously circulating SARS-CoV-2 variants. That left no available neutralizing antibody product in the U.S. for the treatment of COVID-19, according to the IDSA.
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