Europe’s drug regulator is expected to give the go-ahead this week for AstraZeneca’s antibody-based injection for preventing COVID-19 infections, two people familiar with the review said, following U.S. and U.K. approvals.
The treatment is meant for adults whose immune system is too weak to respond to vaccines and offers a new tool to ease the pandemic burden on health care systems. Infections in Europe are on a sharp rise again this month, with the adult vaccination rate stagnating at a little over 83%.
The expected recommendation by the European Medicines Agency (EMA) is set to be confirmed swiftly by the European Commission, which has the final word on market access.
An EMA expert panel on drug assessment is due to discuss AstraZeneca’s Evusheld treatment this week, according an agenda posted on the EMA’s website.
The EMA, which started its real-time review of Evusheld last October, said if the panel came to a conclusion this week, it would communicate its opinion towards the end of this week.
It said on Thursday the review would conclude within weeks and that AstraZeneca’s data was robust.
AstraZeneca, whose COVID-19 vaccine Vaxzevria is primarily being used outside the EU and the United States, declined to comment.
Britain’s medicines regulator approved Evusheld last week. It is given as two consecutive shots in arms.
The U.S. Food and Drug Administration, meanwhile, in December issued an emergency use authorization for Evusheld, which is also known as a passive immunization.
The European Commission in October included Evusheld in a list https://ec.europa.eu/commission/presscorner/detail/en/ip_21_5366 of the 10 most promising candidates for an EU portfolio of COVID-19 treatments, but the bloc has so far not struck a purchase agreement.
The World Health Organization warned last week the pandemic was far from over, citing the highly transmissible Omicron variant and its BA.2 sub-variant as well as the lifting of restrictive measures.
AstraZeneca said in December a lab study had found Evusheld retained neutralizing activity against Omicron.
While vaccines rely on an intact immune system to develop targeted antibodies and infection-fighting cells, Evusheld contains lab-made antibodies designed to linger in the body for months to contain the virus in case of an infection.
The therapy was found to cut the risk of developing symptomatic COVID-19 by 77% in trials, with protection lasting for at least six months. It has also been shown to prevent disease progression when given soon after infection.
One of the sources also said the EMA’s ongoing review of Lagevrio, an oral treatment by Merck & Co and Ridgeback Biotherapeutics to prevent a COVID infection from getting worse, was unlikely to be concluded before the end of April.
The EMA said last week it was difficult to predict how long that review would take. Merck did not immediately respond to a request for comment.
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