FDA: Evusheld no longer authorized to prevent COVID-19 in US ‘until further notice’
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Evusheld is no longer authorized for use to help prevent COVID-19 in the United States “until further notice,” due to a lack of protection against dominant variants, according to new guidance issued by the FDA.
In its updated guidance, the FDA limited the use of Evusheld (tixagevimab plus cilgavimab, AstraZeneca) to when the combined national frequency of variants that are not susceptible to the treatment is 90% or less. The CDC currently projects that non-susceptible variants are responsible for more than 90% of COVID-19 infections in the United States, the statement added.
“This means that Evusheld is not expected to provide protection against developing COVID-19 if exposed to those variants,” the FDA said in the statement. “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.”
In place of Evusheld, the FDA recommended that vulnerable patients who develop COVID-19 should seek medical attention and begin treatment using approved medications including nirmatrelvir/ritonavir (Paxlovid, Pfizer), remdesivir (Veklury, Gilead Sciences) or molnupiravir (Lagevrio, Merck).
Meanwhile, the FDA recommended that health care practitioners and administrators retain their supply of Evusheld in the event that variants demonstrating susceptibility increase in prevalence in the future.
“FDA will continue to work with ASPR [Administration of Strategic Preparedness and Response], the CDC and the National Institutes of Health on surveillance of variants that may impact the use of the therapies authorized for emergency use,” the guidance said.
Perspective
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We have seen this announcement coming for a while and recognize the issue and challenges of resistance to monoclonals. Fortunately, new monoclonals are entering clinical trials as we speak. We believe, however, that in order for this to impact the immunocompromised patient population in a timely manner, the FDA and the European Medicines Agency need to develop an accelerated path for the approval and authorization of these therapies.
I urge patient advocacy groups across disease states to sound this alarm calling for a fast-track regulatory plan that will not require classic controlled trials, which will expose immunocompromised patients to ineffective agents, while assuring safety and providing ongoing data on efficacy designed to protect our most immunocompromised.
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