FDA Halts Authorization of AstraZeneca's Evusheld for Prophylactic Use

By Michael Susin

AstraZeneca PLC said Thursday that it has been notified by the Food and Drug Administration that Evusheld isn't authorized for emergency use in cases of pre-exposure prevention of Covid-19 in the U.S.

The Anglo-Swedish pharma major said that the decision, until further notice, is due to the sustained high frequency of circulating variants that the treatment doesn't retain in vitro neutralization against.

The FDA will reinstate the authorization if the national prevalence of resistant variants decreases to 90% or less on a sustained basis.

AstraZeneca said that it will continue to work with health authorities to collect, assess and share relevant data.

In the same statement the company said that it has started the SUPERNOVA Phase I/III trial of a next-generation long-acting antibody in Covid-19 pre-exposure prophylaxis in an immunocompromised population.

In vitro studies showed that the treatment neutralized all SARS-CoV-2 variants tested to date.

The company expects to make the new long-acting antibody available in the second half of 2023.

Write to Michael Susin at [e-mail]

(END) Dow Jones Newswires

January 26, 2023 13:58 ET (18:58 GMT)

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