Eli Lilly, UnitedHealth Team Up on Pragmatic Study of COVID-19 Antibody Treatment

Eli Lilly and healthcare company UnitedHealth are working together to conduct a pragmatic study of the American pharma titan’s COVID-19 antibody treatment, bamlanivimab (LY-CoV555), a therapy that received Emergency Use Authorization (EUA) from the FDA nearly a month ago.

The trial will enroll up to half a million eligible participants enrolled in a UnitedHealthcare Medicare Advantage plan, with at least 5,000 of them expected to be given bamlanivimab in real-life settings, the healthcare firm said.

“The study will identify and treat a large, diverse population of high-risk individuals for COVID-19 with bamlanivimab under real-world conditions with a goal of reducing the severity of illness and hospitalizations,” UnitedHealth said, noting that patients will be treated using home infusions so that they can remain quarantined.

Daniel Skovronsky, Eli Lilly’s chief scientific officer and president of Lilly Research Laboratories, said that pragmatic studies in diverse populations can shed greater light on the safety and efficacy of SARS-CoV-2 neutralizing antibodies in real-world settings.

The 700-mg dose of Lilly’s monoclonal antibody treatment was cleared by the FDA in November for emergency use in high-risk patients with mild-to-moderate COVID-19 that don’t need to be admitted to the hospital or put on oxygen (DID, Nov. 10).

Though questions about the 700-mg dose’s efficacy arose following granting of the EUA, both the FDA and Eli Lilly have defended the authorization of the dose, the smallest of the three dosages in Lilly’s phase 2 study that some suspect was chosen for clearance over the others in order to conserve the drug’s limited supply. Eli Lilly expects to produce up to 1 million doses by the end of the year and anticipates significantly ramping up production in 2021 (DID, Nov. 12). — James Miessler