Italy's regulator approves conditional use of COVID-19 antibody therapies

MILAN (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 emergency situation.

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.

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