Intended for healthcare professionals


Covid-19: FDA removes US authorisation for antibody drug Evusheld

BMJ 2023; 380 doi: (Published 01 February 2023) Cite this as: BMJ 2023;380:p264
  1. Gareth Iacobucci
  1. The BMJ

The US Food and Drug Administration has withdrawn its emergency use authorisation for the covid-19 antibody drug Evusheld, citing data showing that the treatment is unlikely to be effective against the XBB.1.5 subvariant of omicron now dominant in the United States.

Evusheld, manufactured by AstraZeneca, is a combination of two long acting antibodies, tixagevimab and cilgavimab. It is given as two separate, sequential intramuscular injections.

The FDA first authorised the drug in late 2021 to prevent covid infections in clinically extremely vulnerable people. But in an update issued on 26 January the FDA said that it had decided to withdraw the emergency authorisation.1

“Data show Evusheld is unlikely to be active against certain SARS-CoV-2 variants,” it said. “According to the most recent [Centers for Disease Control and Prevention’s] Nowcast data, these 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.”

It added, “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 US causing infection are susceptible to the product.”

Emerging evidence

The FDA said that several other antiviral treatments—Paxlovid, Veklury (remdesivir), and Lagevrio (molnupiravir)—were “expected to work against currently circulating variants” and were authorised or approved for at-risk patients. “Healthcare providers should assess whether treatments are right for their patients,” it said.

In the UK the Medicines and Healthcare Products Regulatory Agency approved Evusheld for use in March 2022. But last August the UK government said that it would not buy the drug, because of “insufficient data” on the duration of protection it provided against omicron and its subvariants. This remains its position.

A Department of Health and Social Care spokesperson said, “The current and emerging evidence continues to suggest Evusheld may be less effective at treating the covid variants currently dominant in the UK. We will not be procuring doses at this time.

“The National Institute for Health and Care Research is conducting an appraisal that will shortly provide recommendations on the prophylactic use of Evusheld in the NHS. If they consider the treatment to be clinically and cost effective, it will be made available on the NHS in the usual way.”

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