FDA yanks EUA for Lilly’s bebtelovimab COVID-19 antibody

The FDA has pulled the emergency use authorization (EUA) for bebtelovimab, the monoclonal antibody from Eli Lilly (NYSE:LLY), because it no longer adequately protects against the BQ.1 and BQ.1.1 omicron subvariants.

In late November, the BQ.1 variant was responsible for 27.9% of U.S. COVID-19 infections, according to CDC. The BQ.1.1 variant represented 29.4% of infections. Meanwhile, the BA.5 variant made up 19.4% of infections. The BQ.1 and BQ.1.1 variants are likely to grow even more prevalent in the coming weeks.

FDA authorized bebtelovimab in February, which remained effective against the original omicron variant.

Bebtelovimab was the last monoclonal antibody to have an EUA. However, FDA has suspended its authorizations of several other such antibodies during the pandemic with the rise of COVID-19 variants that elude them.

An FDA Health Care Provider Fact Sheet stated that several variants, including the omicron subvariants BQ.1 and BQ.1.1, we…

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FDA authorizes new antibody from Lilly that holds up to omicron

FDA has authorized bebtelovimab, a monoclonal antibody from Eli Lilly and Company (NYSE:LLY), for certain high-risk patients with COVID-19.

The emergency use authorization (EUA) for the antibody covers the treatment of mild-to-moderate COVID-19 in individuals at least 12 years of age who weigh at least 40 kg (about 88 pounds). The EUA is constrained to individuals who are not good candidates for existing approved or authorized alternative COVID-19 therapies.

The authorization covers a single 175-mg intravenous dose of bebtelovimab is 175 mg administered over at least 30 seconds.

Lilly began developing bebtelovimab early in 2021 and confirmed its potency against omicron in pseudovirus and authentic virus testing.

Dr. Daniel Skovronsky

The broadly neutralizing antibody “could be used to fight a highly mutated variant, should one emerge,” said Dr. Daniel Skovronsky, Lill…

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