MILAN, Feb 5 (Reuters) - Italy's medicines regulator AIFA
has given the green light for emergency use of COVID-19 antibody
therapies developed by U.S drugmakers Eli Lilly and
Regeneron, it said on Friday.
The treatments are aimed at patients with mild to moderate
disease who are at risk of their condition worsening, AIFA said.
The regulator's scientific committee said it was appropriate
to provide this treatment option, while also pointing out that
the data is not yet well developed and there is uncertainty
about how much benefit the drugs offer.
"This is a high-risk setting for which no standard treatment
with proven efficacy is currently available," AIFA said, noting
it was giving approval on extraordinary basis due to the
The EU regulator said on Thursday it was reviewing data on
the Eli Lilly and Regeneron antibody therapies.
Regeneron's cocktail of casirivimab and imdevimab was
authorised for emergency use in the United States in November,
and was given to former U.S. President Donald Trump when he was
ill with COVID-19.
Eli Lilly's combination therapy of two antibodies,
bamlanivimab and etesevimab, helped cut the risk of
hospitalization and death in COVID-19 patients by 70%, data from
a late-stage trial showed in January.
(Reporting by Emilio Parodi
Editing by Frances Kerry)