FDA Withdraws EUA for Evusheld


The federal agency does not want clinicians utilizing this neutralizing antibody as newer, circulating COVID-19 strains and efficacy against them is limited.

On Thursday, the FDA withdrew its Emergency Use Authorization for tixagevimab and cilgavimab (Evusheld) in order to limit its use to when the combined frequency of non-susceptible SARS-CoV-2 variants nationally is less than or equal to 90%.

Earlier this month, FDA released a statement saying that Evusheld was unlikely to be active and effectively neutralize against certain SARS-CoV-2 variants such as XBB15, which is a strain circulating the United States. As the similar XBB variant was not neutralized by Evusheld, the FDA believed the treatment will also be ineffective against XBB15.

According to the most recent CDC Nowcast data, the XBB and XBB15 variants are projected to be responsible for more than 90% of current infections in the US. This means that Evusheld is not expected to provide protection against developing COVID-19 if exposed to those variants.

In the notification, the FDA said other therapies including, nirmatrelvir/ritonavir (Paxlovid), remdesivir (Veklury), and molnupiravir (Lagevrio) are expected to work against the variants currently circulating, and that are authorized or approved to treat certain patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death. Health care providers should assess whether treatments are right for their patients.

This comes on the heels of the IDSA’s recent guideline update on neutralizing antibodies, which covered preexposure and postexposure prophylaxis as well as treatment for COVID-19. The IDSA treatment guidelines were replaced with a statement about in vitro resistance to circulating strains in the US. For the preexposure and postexposure prophylaxis portion of the guidelines, IDSA recommended Evusheld as a potential option in other parts of the world where the circulating variants may still be susceptible to it.

Here in the United States, the federal government recommends that facilities and providers with Evusheld retain all product in the event that SARS-CoV-2 variants which are neutralized by Evusheld become more prevalent in the US in the future.

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