U.S. FDA Limits Use Of Regeneron, Lilly COVID-19 Antibody Treatments – Reuters

Jan 24 (Reuters) – The U.S. health regulator revised on Monday the emergency use authorizations for COVID-19 antibody treatments from Regeneron (REGN.O) and Eli Lilly (LLY.N) to limit their use, as the drugs are unlikely to work against the Omicron coronavirus variant.

The Food and Drug Administration (FDA) said the treatments are currently not cleared for use in any U.S. states or territories, but may be authorized 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 (GSK.L) and Vir Biotechnology as well as recently authorized antiviral pills from Pfizer (PFE.N) and Merck & Co (MRK.N). (https://reut.rs/3FVKVHS)

Last month, the U.S. government had paused the 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% 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’ (GILD.O) antiviral COVID-19 drug remdesivir to treat non-hospitalized patients aged 12 years and above. read more

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

Regeneron said it is working with the FDA to bring additional monoclonal antibody treatments to patients.

“Pending regulatory discussions, new therapeutic candidates could enter the clinic in coming months,” the company said in a statement.

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

Reporting by Amruta Khandekar and Ann Maria Shibu; Editing by Devika Syamnath and Sherry Jacob-Phillips

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