Jan 24 (Reuters) - The U.S. health regulator revised on
Monday the emergency use authorizations for COVID-19 antibody
treatments from Regeneron and Eli Lilly 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 and Vir Biotechnology as well as
recently authorized antiviral pills from Pfizer and
Merck & Co. (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' antiviral COVID-19 drug remdesivir to treat
non-hospitalized patients aged 12 years and above.
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)