FDA Issues Update on Evusheld for Immunosuppressed Patients

The US Food and Drug Administration (FDA) on October 3 issued an update to its guidance for Evusheld, notifying health care providers that patients may be at “increased risk for developing COVID-19 when exposed to variants of SARS-CoV-2 that are not neutralized by Evusheld.”

Evusheld combines tixagevimab with cilgavimab to provide pre-exposure prophylaxis (PrEP) against the SARS-CoV-2 virus.

FDA authorized Evusheld through its Emergency Use Authorization (EUA) powers for use in immunocompromised individuals who may not mount an adequate response to COVID-19 vaccination, and for individuals for whom COVID-19 vaccination is not recommended due to a history of a severe adverse reaction,” the agency said in its announcement.

FDA urges caregivers to monitor data on regional variant frequency provided by the Centers for Disease Control and Prevention (CDC) and to discuss this risk with their patients who are immunocompromised.

The agency also said that it “continues to recommend Evusheld as an appropriate option for PrEP to prevent COVID-19, in combination with other preventative measures like getting vaccinated and boosted as recommended, as Evusheld still offers protection against many of the currently circulating variants and may offer protection against future variants.”

—Rebecca Mashaw

Reference:

FDA releases important information about risk of COVID-19 due to certain variants not neutralized by Evusheld. Update. US Food and Drug Administration; October 3, 2022. Accessed October 4, 2022. https://www.fda.gov/drugs/drug-safety-and-availability/fda-releases-important-information-about-risk-covid-19-due-certain-variants-not-neutralized-evusheld