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World News24

World News24

World News24

US FDA limits use of Regeneron, Lilly COVID-19 antibody treatments

Posted on January 25 2022, 00:51am

US FDA limits use of Regeneron, Lilly COVID-19 antibody treatments

WASHINGTON: The US health regulator on Monday (Jan 24) revised the emergency use authorisations for COVID-19 antibody treatments from Regeneron and Eli Lilly to limit their use, as the drugs are unlikely to work against the Omicron variant.

The Food and Drug Administration (FDA) said the treatments are currently not cleared for use in any US states or territories, but may be authorised in certain regions if they work against potential new variants.

The agency highlighted other therapies that are expected to be effective against Omicron, including a rival antibody drug from GlaxoSmithKline and Vir Biotechnology as well as recently authorised antiviral pills from Pfizer and Merck.

The US government in December had paused distribution of Regeneron and Lilly's treatments and said the halt would continue until new data emerges on their efficacy against Omicron.

The highly contagious new variant was estimated to account for more than 99 per cent of cases in the United States as of Jan 15.

GSK and Vir Biotech are boosting production of their drug, sotrovimab to help meet soaring demand in the United States. The FDA has also expanded its approval for the use of Gilead Sciences' antiviral COVID-19 drug remdesivir to treat non-hospitalised patients aged 12 years and above.

The Washington Post earlier in the day reported that the FDA was expected to revise authorisations for Regeneron and Lilly's treatments.

A Regeneron spokesperson had said the regulator would provide any potential communication on the topic.

Lilly had no immediate comment but pointed to its statement from December saying its antibody candidate, bebtelovimab, maintains neutralisation activity against all known variants of concern, including Omicron.

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