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Lilly's (LLY) COVID-19 Drug Gets FDA Nod for Emergency Use
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Eli Lilly & Company (LLY - Free Report) announced that the FDA has granted Emergency Use Authorization (EUA) to its new COVID-19 antibody-drug, bebtelovimab.
The medicine (175 mg), to be given as an intravenous injection, is authorized to treat certain non-hospitalized adults and pediatric (12 years of age and over) patients with mild-to-moderate COVID-19 who are at high risk of progressing to severe disease, including hospitalization or death. The EUA is based on data from the phase II BLAZE-4 study.
Lilly’s stock has declined 14.7% this year so far compared with a decrease of 4.5% for the industry.
Image Source: Zacks Investment Research
Last week, Lilly announced an agreement to supply the U.S. government up to 600,000 doses of its bebtelovimab for at least $720 million, if granted emergency approval by the FDA. Per the deal, Lilly will deliver 600,000 doses no later than Mar 31, 2022 with an option of 500,000 additional doses no later than Jul 31, 2022.
The FDA had granted EUA to Lilly’s antibody cocktail, bamlanivimab plus etesevimab to treat mild-to-moderate COVID-19 in high-risk patients in February 2021. In September last year, the FDA expanded the EUA for the cocktail antibody medicine to include the post-exposure prevention (prophylaxis) for COVID-19 indication.
However, in January this year, the FDA revised the emergency use authorization (EUA) for bamlanivimab plus etesevimab as well as Regeneron Pharmaceuticals’ (REGN - Free Report) cocktail antibody drug, REGEN-COV (casirivimab plus imdevimab). The revision for these two cocktail COVID-19 drugs limited their use in patients who have been infected or exposed to a coronavirus variant that is susceptible to these treatments.
The FDA’s decision to limit the authorized use of Lilly and Regeneron’s cocktail COVID-19 drugs was based on data, which showed that these treatment options are highly unlikely to be effective against the highly contagious Omicron variant, which is now the dominant variant in the United States.
Lilly’s bamlanivimab and bamlanivimab/etesevimab cocktail medicine generated $2.23 billion in revenues in 2021. Regeneron generated $6.2 billion from the sale of REGEN-COV.
However, pseudovirus and authentic virus testing of bebtelovimab showed that the antibody retains full neutralizing activity against Omicron. Also, an authentic virus analysis of bebtelovimab demonstrated that bebtelovimab neutralizes all known variants of concern, including Omicron.
The fast emergency approval of bebtelovimab should make up for any lost revenues from bamlanivimab/etesevimab cocktail.
Other new options available to treat COVID-19 are Pfizer’s (PFE - Free Report) and Merck’s (MRK - Free Report) oral antiviral pills, Paxlovid and molnupiravir, respectively.
Pfizer’s Paxlovid and Merck’s molnupiravir are the first oral treatment options in the non-hospitalized setting for COVID-19 infection that were authorized for emergency use in December 2021 in the United States. Both Pfizer and Merck have released pre-clinical/clinical data, which has shown that their respective pills are active against the Omicron variant.
Pfizer’s Paxlovid generated $76 million in U.S. sales in the fourth quarter of 2021. Pfizer expects Paxlovid to generate sales of $22 billion in 2022.
Merck’s molnupiravir generated sales of $952 million during the fourth quarter. Merck expects sales of $5 billion to $6 billion from molnupiravir in 2022.
Image: Bigstock
Lilly's (LLY) COVID-19 Drug Gets FDA Nod for Emergency Use
Eli Lilly & Company (LLY - Free Report) announced that the FDA has granted Emergency Use Authorization (EUA) to its new COVID-19 antibody-drug, bebtelovimab.
The medicine (175 mg), to be given as an intravenous injection, is authorized to treat certain non-hospitalized adults and pediatric (12 years of age and over) patients with mild-to-moderate COVID-19 who are at high risk of progressing to severe disease, including hospitalization or death. The EUA is based on data from the phase II BLAZE-4 study.
Lilly’s stock has declined 14.7% this year so far compared with a decrease of 4.5% for the industry.
Last week, Lilly announced an agreement to supply the U.S. government up to 600,000 doses of its bebtelovimab for at least $720 million, if granted emergency approval by the FDA. Per the deal, Lilly will deliver 600,000 doses no later than Mar 31, 2022 with an option of 500,000 additional doses no later than Jul 31, 2022.
The FDA had granted EUA to Lilly’s antibody cocktail, bamlanivimab plus etesevimab to treat mild-to-moderate COVID-19 in high-risk patients in February 2021. In September last year, the FDA expanded the EUA for the cocktail antibody medicine to include the post-exposure prevention (prophylaxis) for COVID-19 indication.
However, in January this year, the FDA revised the emergency use authorization (EUA) for bamlanivimab plus etesevimab as well as Regeneron Pharmaceuticals’ (REGN - Free Report) cocktail antibody drug, REGEN-COV (casirivimab plus imdevimab). The revision for these two cocktail COVID-19 drugs limited their use in patients who have been infected or exposed to a coronavirus variant that is susceptible to these treatments.
The FDA’s decision to limit the authorized use of Lilly and Regeneron’s cocktail COVID-19 drugs was based on data, which showed that these treatment options are highly unlikely to be effective against the highly contagious Omicron variant, which is now the dominant variant in the United States.
Lilly’s bamlanivimab and bamlanivimab/etesevimab cocktail medicine generated $2.23 billion in revenues in 2021. Regeneron generated $6.2 billion from the sale of REGEN-COV.
However, pseudovirus and authentic virus testing of bebtelovimab showed that the antibody retains full neutralizing activity against Omicron. Also, an authentic virus analysis of bebtelovimab demonstrated that bebtelovimab neutralizes all known variants of concern, including Omicron.
The fast emergency approval of bebtelovimab should make up for any lost revenues from bamlanivimab/etesevimab cocktail.
Other new options available to treat COVID-19 are Pfizer’s (PFE - Free Report) and Merck’s (MRK - Free Report) oral antiviral pills, Paxlovid and molnupiravir, respectively.
Pfizer’s Paxlovid and Merck’s molnupiravir are the first oral treatment options in the non-hospitalized setting for COVID-19 infection that were authorized for emergency use in December 2021 in the United States. Both Pfizer and Merck have released pre-clinical/clinical data, which has shown that their respective pills are active against the Omicron variant.
Pfizer’s Paxlovid generated $76 million in U.S. sales in the fourth quarter of 2021. Pfizer expects Paxlovid to generate sales of $22 billion in 2022.
Merck’s molnupiravir generated sales of $952 million during the fourth quarter. Merck expects sales of $5 billion to $6 billion from molnupiravir in 2022.
Lilly currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.