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