LLY Eli Lilly and Co

By Peter Loftus 

A combination of two Eli Lilly & Co. antibody-based drugs to treat recently diagnosed Covid-19 was authorized by federal health regulators, the latest treatment aimed to help people at high risk of severe disease from avoiding hospitalization.

The move by the U.S. Food and Drug Administration on Tuesday night allows doctors to add a new monoclonal antibody, named etesevimab, to one called bamlanivimab that the agency authorized last year.

The combination, administered together via a single intravenous infusion, is cleared for patients who are at high risk of worsening to severe Covid-19 including those 65 and older or who have certain medical conditions.

Monoclonal antibodies are engineered proteins that mimic the immune system's ability to fight off viruses. Regeneron Pharmaceuticals Inc. makes a similar antibody-based Covid-19 treatment that previously received FDA authorization.

Companies are developing Covid-19 antibody treatments that are more convenient to take and can tackle emerging variants.

Lilly co-developed bamlanivimab with Canadian company AbCellera Biologics Inc. It was derived from a blood sample taken from one of the first U.S. patients to recover from Covid-19. Lilly licensed the second antibody, etesevimab, from Junshi Biosciences of China.

A 1,035-person study found that the two-drug cocktail reduced the combined risk of death and hospitalization by 70% compared with patients who received a placebo. Some 7% of patients in the study who received the placebo died or were hospitalized for Covid-19, versus 2% of those who received the Lilly combination. Some patients had side effects including certain allergic reactions.

Lilly and its manufacturing partner Amgen Inc. plan to make up to one million doses of etesevimab by mid-2021. About 100,000 doses are ready immediately and an additional 150,000 are expected to be available throughout the first quarter, Lilly said.

The U.S. government previously agreed to purchase 950,000 doses of the first Lilly antibody, bamlanivimab, and has directed the allocation of doses to health-care providers. Lilly said Tuesday it expects the procurement and allocation of the new two-antibody cocktail to mirror the same process.

Write to Peter Loftus at peter.loftus@wsj.com

(END) Dow Jones Newswires

February 10, 2021 08:58 ET (13:58 GMT)

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