AstraZeneca’s Covid-19 drug loses US approval due to mutation

WASHINGTON – AstraZeneca Plc’s Covid-19 antibody drug is no longer approved for use in the United States, regulators said Thursday.

The Astra potion called Evsheld, Approved December 2021 to prevent Covid-19 infection It is effective in people at high risk, but mutations in the virus have made it less effective.

At this time, less than 10% of the currently circulating variant in the United States appears to respond to Astra treatment, the U.S. Food and Drug Administration said in a statement.

Meanwhile, Astra said in a statement that it is testing a next-generation long-acting antibody to prevent Covid-19 in immunocompromised people, pending regulatory approval and making the drug available in the second half of 2023. We aim to make it possible.

In early lab studies, the next-generation antibody was effective against all Covid-19 variants tested, the company says, including those that interfered with other drugs. .

“Approximately 2% of the world’s population is considered at high risk of poor Covid-19 vaccination response and may benefit from monoclonal antibodies for Covid-19 protection,” it said. the company said.

Earlier this month, the agency warned that Evusheld was unlikely to work against the rapidly spreading XBB.1.5 variant, which has grown to account for nearly half of the country’s Covid-19 cases. , this drug was on the market until now.

This is not just an Astra antibody problem.

A panel from the US National Institutes of Health had recommended against using monoclonal antibodies to treat or prevent Covid-19 in high-risk people because the drugs are becoming less effective.

Evusheld was the last antibody treatment left on the market after the FDA withdrew approval of other drugs because of the mutation.

All Covid-19 antibody drugs manufactured by Eli Lilly & Co, Regeneron Pharmaceuticals Inc and a partnership between GSK Plc and Vir Biotechnology Inc have also been withdrawn from the market.bloomberg