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Eli Lilly and Company (LLY - Free Report) announced new data from a phase III study, which showed that the combination of its COVID-19 antibody candidates bamlanivimab (LY-CoV555) plus etesevimab (LY-CoV016) significantly reduced COVID-19-related hospitalizations and deaths in high-risk patients having recently been diagnosed with COVID-19.
The phase III BLAZE-1 study met the primary endpoint by demonstrating that the combo of bamlanivimab (2800 mg) + etesevimab (2800 mg) reduced risk of COVID-19 hospitalizations and death by 70%. The study also met all key secondary endpoints wherein bamlanivimab + etesevimab demonstrated high statistical significance, which proves that the therapy reduced viral load and accelerated symptom resolution.
Notably, across the 1,035 patients who were investigated in the study, a total of 10 deaths were reported, all of which occurred in the placebo arm, while no death was reported in patients taking bamlanivimab and etesevimab together.
Bamlanivimab was granted Emergency Use Authorization (“EUA”) by the FDA in November 2020 for the treatment of patients at high risk for progressing to severe COVID-19 illness or hospitalization, which was based on data from the BLAZE-1 study. A request to grant EUA to the bamlanivimab/etesevimab combination to treat mild-to-moderate COVID-19 in high-risk patients is also under review with the FDA.
Additionally, Lilly is exploring the lower doses of bamlanivimab and etesevimab together in the BLAZE-4 study. Per the company, initial results from this ongoing study provide viral load and pharmacodynamic/pharmacokinetic data, which showed that lower doses of bamlanivimab (700 mg) and etesevimab (1400 mg) together are similar to the higher doses of bamlanivimab (2800 mg) and etesevimab (2800 mg) together.
Last week, Lilly announced data from the phase III BLAZE-2 study, which showed that bamlanivimab significantly reduced the risk of contracting symptomatic COVID-19 infection in residents and staff of long-term care facilities in the United States.
Shares of Lilly have rallied 52.7% in the past year compared with the industry’s increase of 9.7%.
We note that other than bamlanivimab, the FDA 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.
Meanwhile, Regeneron’s (REGN - Free Report) novel investigational antibody cocktail, casirivimab and imdevimab administered together, was also granted EUA by the FDA in November for the treatment of mild-to-moderate COVID-19 in patients who are at high risk of progressing to severe COVID-19 and/or hospitalization.
Experts extracted 7 stocks from the list of 220 Zacks Rank #1 Strong Buys that has beaten the market more than 2X over with a stunning average gain of +24.4% per year.
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Lilly's (LLY) Bamlanivimab Combo Lowers COVID-19 Hospitalization
Eli Lilly and Company (LLY - Free Report) announced new data from a phase III study, which showed that the combination of its COVID-19 antibody candidates bamlanivimab (LY-CoV555) plus etesevimab (LY-CoV016) significantly reduced COVID-19-related hospitalizations and deaths in high-risk patients having recently been diagnosed with COVID-19.
The phase III BLAZE-1 study met the primary endpoint by demonstrating that the combo of bamlanivimab (2800 mg) + etesevimab (2800 mg) reduced risk of COVID-19 hospitalizations and death by 70%. The study also met all key secondary endpoints wherein bamlanivimab + etesevimab demonstrated high statistical significance, which proves that the therapy reduced viral load and accelerated symptom resolution.
Notably, across the 1,035 patients who were investigated in the study, a total of 10 deaths were reported, all of which occurred in the placebo arm, while no death was reported in patients taking bamlanivimab and etesevimab together.
Bamlanivimab was granted Emergency Use Authorization (“EUA”) by the FDA in November 2020 for the treatment of patients at high risk for progressing to severe COVID-19 illness or hospitalization, which was based on data from the BLAZE-1 study. A request to grant EUA to the bamlanivimab/etesevimab combination to treat mild-to-moderate COVID-19 in high-risk patients is also under review with the FDA.
Additionally, Lilly is exploring the lower doses of bamlanivimab and etesevimab together in the BLAZE-4 study. Per the company, initial results from this ongoing study provide viral load and pharmacodynamic/pharmacokinetic data, which showed that lower doses of bamlanivimab (700 mg) and etesevimab (1400 mg) together are similar to the higher doses of bamlanivimab (2800 mg) and etesevimab (2800 mg) together.
Last week, Lilly announced data from the phase III BLAZE-2 study, which showed that bamlanivimab significantly reduced the risk of contracting symptomatic COVID-19 infection in residents and staff of long-term care facilities in the United States.
Shares of Lilly have rallied 52.7% in the past year compared with the industry’s increase of 9.7%.
We note that other than bamlanivimab, the FDA 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.
Meanwhile, Regeneron’s (REGN - Free Report) novel investigational antibody cocktail, casirivimab and imdevimab administered together, was also granted EUA by the FDA in November for the treatment of mild-to-moderate COVID-19 in patients who are at high risk of progressing to severe COVID-19 and/or hospitalization.
Zacks Rank
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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