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Lilly (LLY)/UnitedHealth Launch COVID-19 Study on Bamlanivimab

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Eli Lilly & Company (LLY - Free Report) announced a partnership with UnitedHealth Group’s (UNH - Free Report) research and innovation center, Optum Labs to conduct a pragmatic study to evaluate its COVID-19 antibody drug, bamlanivimab (LY-CoV555)in high-risk, COVID-19 infected individuals.

Bamlanivimab (700 mg injection) was granted Emergency Use Authorization (EUA) by the FDA last month as a monotherapy for the treatment of recently diagnosed mild-to-moderate COVID-19 illness at high risk of progressing to severe COVID-19 or hospitalization.

The study will evaluate the efficacy and safety of bamlanivimab versus a propensity-matched control in people who meet the EUA criteria. The large pragmatic study to be conducted across a diverse population of high-risk individuals for COVID-19 will give further understanding of such antibody drugs in a real-world setting. The study will detect and treat high-risk symptomatic patients who test positive for COVID-19 and includes in-home testing and in-home infusions. This will help identify, intercept and treat COVID-19 early. The study will enroll up to 500,000 people. At least 5,000 of them are expected to be administered bamlanivimab therapy.

Lilly’s shares were up 3% on Friday in response to the news. So far this year, Lilly’s stock has risen 13% compared with an increase of 2.9% for the industry



The EUA for bamlanivimab was based on data from the phase II BLAZE-1 study. The study also evaluated bamlanivimab in combination with Lilly’s another COVID-19 antibody candidate etesevimab (LY-CoV016) in patients recently diagnosed with COVID-19 in the ambulatory (non-hospitalized) setting. Another study, BLAZE-2, a phase III study of bamlanivimab for the prevention (prophylaxis) of COVID-19 in residents and staff at long-term care facilities is also ongoing.

Meanwhile, a NIH-led ACTIV-2 study is testing bamlanivimab in recently diagnosed mild-to-moderate COVID-19 patients.

In November, the FDA also granted EUA to Lilly and Incyte’s (INCY - Free Report) oral JAK inhibitor Olumiant for use in combination with Gilead’s (GILD - Free Report) remdesivir in hospitalized COVID-19 patients based on positive phase III results from the ACTT-2 study.

Lilly currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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