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Eli Lilly & Company (LLY - Free Report) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a position opinion recommending approval of Lilly’s COVID-19 antibody drug, bamlanivimab, as a monotherapy as well as in combination with another antibody therapy, etesevimab for the treatment of confirmed COVID-19 in Europe.
The recommendation applies to patients aged 12 years and older who do not require supplemental oxygen for COVID-19 and who are at high risk of progressing to severe COVID-19.
The CHMP nod was based on phase II and III data from theBLAZE-1 study, which showed that the bamlanivimab/etesevimab combinationreduced risk of COVID-19 hospitalizations and death by 70% in high-risk patients recently diagnosed with COVID-19. The study also demonstratedthat bamlanivimab, as a monotherapy, reduced viral load and symptoms and also reduced COVID-19 hospitalizations by approximately 70%.
Last month, the FDA had granted Emergency Use Authorization (EUA) to a combination bamlanivimab (700 mg) and etesevimab (1400 mg) for the treatment of mild-to-moderate COVID-19 in patients who are at high risk of progressing to severe COVID-19.
Earlier, bamlanivimab was granted EUA by the FDA in November 2020 as a monotherapy for high-risk patients recently diagnosed with mild-to-moderate COVID-19. Bamlanivimab alone is now authorized for emergency/temporary use in numerous countries.
So far this year, Lilly’s stock has risen 23.1% against a decrease of 1.4% for the industry.
Meanwhile, other studies are ongoing on bamlanivimab in other patient populations and also in combination with etesevimab. In February, Lilly announced a deal with Vir Biotech (VIR - Free Report) and Glaxo (GSK - Free Report) to expand its ongoing BLAZE-4 study to evaluate bamlanivimab (700mg) with Vir Biotech/Glaxo’s investigational COVID-19 antibody, VIR-7831 (500mg) in low-risk patients with mild-to-moderate COVID-19.
Bamlanivimab was a key driver of Lilly’s sales growth in the fourth quarter, contributing $871.2 million in sales due to a key supply contract with the U.S. government. In fact, in 2021, Lilly expects to generate revenues in the range of $1-$2 billion from COVID-19 therapies.
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 remdesivir in hospitalized COVID-19 patients.
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
You know this company from its past glory days, but few would expect that it’s poised for a monster turnaround. Fresh from a successful repositioning and flush with A-list celeb endorsements, it could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in a little more than 9 months and Nvidia which boomed +175.9% in one year.
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Lilly (LLY) COVID-19 Antibody Bamlanivimab Gets CHMP Nod
Eli Lilly & Company (LLY - Free Report) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a position opinion recommending approval of Lilly’s COVID-19 antibody drug, bamlanivimab, as a monotherapy as well as in combination with another antibody therapy, etesevimab for the treatment of confirmed COVID-19 in Europe.
The recommendation applies to patients aged 12 years and older who do not require supplemental oxygen for COVID-19 and who are at high risk of progressing to severe COVID-19.
The CHMP nod was based on phase II and III data from theBLAZE-1 study, which showed that the bamlanivimab/etesevimab combinationreduced risk of COVID-19 hospitalizations and death by 70% in high-risk patients recently diagnosed with COVID-19. The study also demonstratedthat bamlanivimab, as a monotherapy, reduced viral load and symptoms and also reduced COVID-19 hospitalizations by approximately 70%.
Last month, the FDA had granted Emergency Use Authorization (EUA) to a combination bamlanivimab (700 mg) and etesevimab (1400 mg) for the treatment of mild-to-moderate COVID-19 in patients who are at high risk of progressing to severe COVID-19.
Earlier, bamlanivimab was granted EUA by the FDA in November 2020 as a monotherapy for high-risk patients recently diagnosed with mild-to-moderate COVID-19. Bamlanivimab alone is now authorized for emergency/temporary use in numerous countries.
So far this year, Lilly’s stock has risen 23.1% against a decrease of 1.4% for the industry.
Meanwhile, other studies are ongoing on bamlanivimab in other patient populations and also in combination with etesevimab. In February, Lilly announced a deal with Vir Biotech (VIR - Free Report) and Glaxo (GSK - Free Report) to expand its ongoing BLAZE-4 study to evaluate bamlanivimab (700mg) with Vir Biotech/Glaxo’s investigational COVID-19 antibody, VIR-7831 (500mg) in low-risk patients with mild-to-moderate COVID-19.
Bamlanivimab was a key driver of Lilly’s sales growth in the fourth quarter, contributing $871.2 million in sales due to a key supply contract with the U.S. government. In fact, in 2021, Lilly expects to generate revenues in the range of $1-$2 billion from COVID-19 therapies.
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 remdesivir in hospitalized COVID-19 patients.
Lilly currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Zacks Names “Single Best Pick to Double”
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
You know this company from its past glory days, but few would expect that it’s poised for a monster turnaround. Fresh from a successful repositioning and flush with A-list celeb endorsements, it could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in a little more than 9 months and Nvidia which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>