EU Regulator Reviewing Lilly, Regeneron COVID-19 Antibody Therapies

By Reuters Staff

February 05, 2021

(Reuters) Europe's drugs regulator said on Thursday it was reviewing data on COVID-19 antibody therapies developed by U.S. drugmakers Eli Lilly and Regeneron for use in some patients.

Two separate reviews of combination treatments by the drugmakers have been started based on trials in COVID-19 patients who do not need oxygen support and are at high risk of their condition worsening, the European Medicines Agency (EMA) said.

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.

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 during his COVID-19 infection.

The EMA also said it was studying the use of Lilly's bamlanivimab as a singular therapy. The drug has already received emergency use approval in high-risk patients in the United States with mild to moderate COVID-19.

However, a recent laboratory experiment published ahead of peer review found that the South African virus variant largely escapes Lilly's bamlanivimab, and that the effect of Regeneron's casirivimab is also greatly reduced against that variant (https://bit.ly/39stAcF).

Lilly has announced that it is already testing a new antibody against the South African variant (https://reut.rs/39Kx5ep).

Any recommendations made by the EMA's human medicine's committee will have to be formally approved by the European Commission.

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