Jan 24 (Reuters) - The U.S. Food and Drug Administration
(FDA) is likely to restrict the use of COVID-19 antibody
treatments from Regeneron and Eli Lilly as they
are ineffective against the Omicron variant, the Washington Post
reported on Monday.
The FDA action will involve revising the emergency use
authorizations for the monoclonal antibodies, the report said https://wapo.st/3KDk1YI,
citing two senior administration health officials.
However, the agency will not revoke the emergency use
authorizations in case the drugs work against a future COVID-19
variant, according to the report.
The FDA did not immediately respond to a Reuters request for
comment, while a Regeneron spokesperson 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 neutralization activity against all known variants of
concern, including Omicron.
The U.S. government in December paused distribution of the
treatments and said the halt would continue until new data
emerges on their efficacy against Omicron, which has quickly
become the dominant strain in the United States and several
other countries. (https://reut.rs/3FVKVHS)
U.S. health agencies, however, had said that GlaxoSmithKline
and Vir Biotechnology's rival drug sotrovimab
appeared to work against the variant and resumed shipments of
GSK and Vir Biotech are boosting production of their drug to
help meet soaring demand in the United States.
(Reporting by Amruta Khandekar; Editing by Devika Syamnath)