The US Meals and Drug Administration has withdrawn its emergency use authorisation for the covid-19 antibody drug Evusheld, citing information exhibiting that the remedy is unlikely to be efficient towards the XBB.1.5 subvariant of omicron now dominant in the US.
Evusheld, manufactured by AstraZeneca, is a mix of two lengthy performing antibodies, tixagevimab and cilgavimab. It’s given as two separate, sequential intramuscular injections.
The FDA first authorised the drug in late 2021 to stop covid infections in clinically extraordinarily susceptible individuals. However in an replace issued on 26 January the FDA stated that it had determined to withdraw the emergency authorisation.1
“Data show Evusheld is unlikely to be active against certain SARS-CoV-2 variants,” it stated. “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.”
The FDA stated that a number of different antiviral therapies—Paxlovid, Veklury (remdesivir), and Lagevrio (molnupiravir)—have been “expected to work against currently circulating variants” and have been authorised or accepted for at-risk sufferers. “Healthcare providers should assess whether treatments are right for their patients,” it stated.
Within the UK the Medicines and Healthcare Merchandise Regulatory Company accepted Evusheld for use in March 2022. However final August the UK authorities stated that it will not purchase the drug, due to “insufficient data” on the period of safety it supplied towards omicron and its subvariants. This stays its place.
A Division of Well being and Social Care spokesperson stated, “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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