What do we know about Eli Lilly's COVID-19 treatments?
What do we know about Eli Lilly's COVID-19 treatments?
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The United States Food and Drug Administration (U.S. FDA) recently issued two Emergency Use Authorization (EUAs) for American pharmaceutical company Eli Lilly's most recent COVID-19 treatments. The first emergency use authorization was issued on November 19, 2020, for bamlanivimab, an antibody treatment. Bamlanivimab has been shown to reduce emergency room visits and hospitalizations in patients who receive the medication quickly after their diagnosis, according to early studies. No benefit has been shown in hospitalized patients with the virus. The treatment was developed with collaborators including Vancouver-based AbCellera and the U.S. National Institutes of Health. Bamlanivimab is a monoclonal antibody drug that mimics the immune system’s own antibodies that fight off harmful antigens such as viruses (like COVID-19). In this way, the medication might be able to help block the virus from entering and infecting healthy human cells. This drug should be dispensed as soon as possible after a person tests positive for the virus and within 10 days of developing systems. Bamlanivimab is authorized for people 12 years of age and older who weigh at least 40 kilograms (88 pounds) and who may be at risk for developing a severe case of COVID-19 infection or be hospitalized due to its impacts. Bamlanivimab was developed from the blood of a recovered patient who had developed antibodies to the virus. The data used to support this emergency use authorization was based on a phase two randomized clinical trial in 465 non-hospitalized adults with mild to moderate COVID-19 symptoms. Patients treated with bamlanivimab showed reduced viral load and rates of symptoms and hospitalization in comparison with those who did not receive the treatment. On November 19, 2020, (U.S. FDA) issued an EUA for the emergency use of Eli Lilly's drug baricitinib to be used in combination with another COVID-19 U.S. FDA-approved treatment, remdesivir, in adult patients who have been hospitalized with COVID-19. This treatment, which also goes by the brand name Olumiant, is normally used to treat rheumatoid arthritis and was developed in partnership with Incyte. In comparison to treating patients with remdesivir alone, baricitinib was shown to reduce time to recovery, when combined with the remdesivir. The safety of this investigational therapy is still being studied, but this medication combination was authorized for patients two years of age or older with suspected or confirmed cases of the virus who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). The combination of drugs improved patients' median time to recovery from eight to seven days compared to remdesivir alone, a 12.5% improvement in the 1,000 patient study that began on May 8,2020, to assess the efficacy and safety of baricitinib plus remdesivir versus remdesivir in hospitalized patients with COVID-19. The proportion of patients who progressed to ventilation, or died by day 29, was 23% lower when given both drugs in comparison to remdesivir alone. By day 29, deaths among patients were also reduced by 35% for the combination treatment when compared to remdesivir by itself. The recommended dose for baricitinib in COVID-19 patients is 4 milligrams once daily for 14 days or until hospital discharge.
The United States Food and Drug Administration (U.S. FDA) recently issued two Emergency Use Authorization (EUAs) for American pharmaceutical company Eli Lilly's most recent COVID-19 treatments. The first emergency use authorization was issued on November 19, 2020, for bamlanivimab, an antibody treatment. Bamlanivimab has been shown to reduce emergency room visits and hospitalizations in patients who receive the medication quickly after their diagnosis, according to early studies. No benefit has been shown in hospitalized patients with the virus. The treatment was developed with collaborators including Vancouver-based AbCellera and the U.S. National Institutes of Health. Bamlanivimab is a monoclonal antibody drug that mimics the immune system’s own antibodies that fight off harmful antigens such as viruses (like COVID-19). In this way, the medication might be able to help block the virus from entering and infecting healthy human cells. This drug should be dispensed as soon as possible after a person tests positive for the virus and within 10 days of developing systems. Bamlanivimab is authorized for people 12 years of age and older who weigh at least 40 kilograms (88 pounds) and who may be at risk for developing a severe case of COVID-19 infection or be hospitalized due to its impacts. Bamlanivimab was developed from the blood of a recovered patient who had developed antibodies to the virus. The data used to support this emergency use authorization was based on a phase two randomized clinical trial in 465 non-hospitalized adults with mild to moderate COVID-19 symptoms. Patients treated with bamlanivimab showed reduced viral load and rates of symptoms and hospitalization in comparison with those who did not receive the treatment. On November 19, 2020, (U.S. FDA) issued an EUA for the emergency use of Eli Lilly's drug baricitinib to be used in combination with another COVID-19 U.S. FDA-approved treatment, remdesivir, in adult patients who have been hospitalized with COVID-19. This treatment, which also goes by the brand name Olumiant, is normally used to treat rheumatoid arthritis and was developed in partnership with Incyte. In comparison to treating patients with remdesivir alone, baricitinib was shown to reduce time to recovery, when combined with the remdesivir. The safety of this investigational therapy is still being studied, but this medication combination was authorized for patients two years of age or older with suspected or confirmed cases of the virus who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). The combination of drugs improved patients' median time to recovery from eight to seven days compared to remdesivir alone, a 12.5% improvement in the 1,000 patient study that began on May 8,2020, to assess the efficacy and safety of baricitinib plus remdesivir versus remdesivir in hospitalized patients with COVID-19. The proportion of patients who progressed to ventilation, or died by day 29, was 23% lower when given both drugs in comparison to remdesivir alone. By day 29, deaths among patients were also reduced by 35% for the combination treatment when compared to remdesivir by itself. The recommended dose for baricitinib in COVID-19 patients is 4 milligrams once daily for 14 days or until hospital discharge.
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What our experts say
The United States Food and Drug Administration (U.S. FDA) recently issued two Emergency Use Authorization (EUAs) for American pharmaceutical company Eli Lilly's most recent COVID-19 treatments.
The first emergency use authorization was issued on November 19, 2020, for bamlanivimab, an antibody treatment. Bamlanivimab has been shown to reduce emergency room visits and hospitalizations in patients who receive the medication quickly after their diagnosis, according to early studies. No benefit has been shown in hospitalized patients with the virus. The treatment was developed with collaborators including Vancouver-based AbCellera and the U.S. National Institutes of Health.
Bamlanivimab is a monoclonal antibody drug that mimics the immune system’s own antibodies that fight off harmful antigens such as viruses (like COVID-19). In this way, the medication might be able to help block the virus from entering and infecting healthy human cells. This drug should be dispensed as soon as possible after a person tests positive for the virus and within 10 days of developing systems.
Bamlanivimab is authorized for people 12 years of age and older who weigh at least 40 kilograms (88 pounds) and who may be at risk for developing a severe case of COVID-19 infection or be hospitalized due to its impacts. Bamlanivimab was developed from the blood of a recovered patient who had developed antibodies to the virus.
The data used to support this emergency use authorization was based on a phase two randomized clinical trial in 465 non-hospitalized adults with mild to moderate COVID-19 symptoms. Patients treated with bamlanivimab showed reduced viral load and rates of symptoms and hospitalization in comparison with those who did not receive the treatment.
On November 19, 2020, (U.S. FDA) issued an EUA for the emergency use of Eli Lilly's drug baricitinib to be used in combination with another COVID-19 U.S. FDA-approved treatment, remdesivir, in adult patients who have been hospitalized with COVID-19. This treatment, which also goes by the brand name Olumiant, is normally used to treat rheumatoid arthritis and was developed in partnership with Incyte.
In comparison to treating patients with remdesivir alone, baricitinib was shown to reduce time to recovery, when combined with the remdesivir. The safety of this investigational therapy is still being studied, but this medication combination was authorized for patients two years of age or older with suspected or confirmed cases of the virus who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
The combination of drugs improved patients' median time to recovery from eight to seven days compared to remdesivir alone, a 12.5% improvement in the 1,000 patient study that began on May 8,2020, to assess the efficacy and safety of baricitinib plus remdesivir versus remdesivir in hospitalized patients with COVID-19. The proportion of patients who progressed to ventilation, or died by day 29, was 23% lower when given both drugs in comparison to remdesivir alone. By day 29, deaths among patients were also reduced by 35% for the combination treatment when compared to remdesivir by itself. The recommended dose for baricitinib in COVID-19 patients is 4 milligrams once daily for 14 days or until hospital discharge.
The United States Food and Drug Administration (U.S. FDA) recently issued two Emergency Use Authorization (EUAs) for American pharmaceutical company Eli Lilly's most recent COVID-19 treatments.
The first emergency use authorization was issued on November 19, 2020, for bamlanivimab, an antibody treatment. Bamlanivimab has been shown to reduce emergency room visits and hospitalizations in patients who receive the medication quickly after their diagnosis, according to early studies. No benefit has been shown in hospitalized patients with the virus. The treatment was developed with collaborators including Vancouver-based AbCellera and the U.S. National Institutes of Health.
Bamlanivimab is a monoclonal antibody drug that mimics the immune system’s own antibodies that fight off harmful antigens such as viruses (like COVID-19). In this way, the medication might be able to help block the virus from entering and infecting healthy human cells. This drug should be dispensed as soon as possible after a person tests positive for the virus and within 10 days of developing systems.
Bamlanivimab is authorized for people 12 years of age and older who weigh at least 40 kilograms (88 pounds) and who may be at risk for developing a severe case of COVID-19 infection or be hospitalized due to its impacts. Bamlanivimab was developed from the blood of a recovered patient who had developed antibodies to the virus.
The data used to support this emergency use authorization was based on a phase two randomized clinical trial in 465 non-hospitalized adults with mild to moderate COVID-19 symptoms. Patients treated with bamlanivimab showed reduced viral load and rates of symptoms and hospitalization in comparison with those who did not receive the treatment.
On November 19, 2020, (U.S. FDA) issued an EUA for the emergency use of Eli Lilly's drug baricitinib to be used in combination with another COVID-19 U.S. FDA-approved treatment, remdesivir, in adult patients who have been hospitalized with COVID-19. This treatment, which also goes by the brand name Olumiant, is normally used to treat rheumatoid arthritis and was developed in partnership with Incyte.
In comparison to treating patients with remdesivir alone, baricitinib was shown to reduce time to recovery, when combined with the remdesivir. The safety of this investigational therapy is still being studied, but this medication combination was authorized for patients two years of age or older with suspected or confirmed cases of the virus who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
The combination of drugs improved patients' median time to recovery from eight to seven days compared to remdesivir alone, a 12.5% improvement in the 1,000 patient study that began on May 8,2020, to assess the efficacy and safety of baricitinib plus remdesivir versus remdesivir in hospitalized patients with COVID-19. The proportion of patients who progressed to ventilation, or died by day 29, was 23% lower when given both drugs in comparison to remdesivir alone. By day 29, deaths among patients were also reduced by 35% for the combination treatment when compared to remdesivir by itself. The recommended dose for baricitinib in COVID-19 patients is 4 milligrams once daily for 14 days or until hospital discharge.
Context and background
The U.S. FDA has recently approved several emergency use authorization for different emergency treatments in response to the COVID-19 pandemic. Despite the rapid speed at which vaccines and other treatments have been developed, tested, and manufactured in for COVID-19, all medications must still undergo clinical trials, safety and efficacy reviews, pass other major regulatory standards, and be approved by an impartial body of experts before being issued for emergency use authorization or full authorization. By the time most of these drugs are being used on patients, they have been tested and evaluated on thousands of volunteer participants and determined to be safe before that time.
The U.S. FDA has recently approved several emergency use authorization for different emergency treatments in response to the COVID-19 pandemic. Despite the rapid speed at which vaccines and other treatments have been developed, tested, and manufactured in for COVID-19, all medications must still undergo clinical trials, safety and efficacy reviews, pass other major regulatory standards, and be approved by an impartial body of experts before being issued for emergency use authorization or full authorization. By the time most of these drugs are being used on patients, they have been tested and evaluated on thousands of volunteer participants and determined to be safe before that time.
Resources
- Baricitinib Receives Emergency Use Authorization from the FDA for the Treatment of Hospitalized Patients with COVID-19 (Lilly)
- Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibody for Treatment of COVID-19 (U.S. FDA)
- Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19 (U.S. FDA)
- Eli Lilly’s Antibody Treatment Gets Emergency F.D.A. Approval (NYT)
- Eli Lilly and AbCellera Win EUA for COVID-19 Antibody Treatment (BioSpace)
- FDA Grants EUA to Combination of Olumiant and Remdesivir in Hospitalized COVID-19 Patients (BioSpace)
- Baricitinib Receives Emergency Use Authorization from the FDA for the Treatment of Hospitalized Patients with COVID-19 (Lilly)
- Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibody for Treatment of COVID-19 (U.S. FDA)
- Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19 (U.S. FDA)
- Eli Lilly’s Antibody Treatment Gets Emergency F.D.A. Approval (NYT)
- Eli Lilly and AbCellera Win EUA for COVID-19 Antibody Treatment (BioSpace)
- FDA Grants EUA to Combination of Olumiant and Remdesivir in Hospitalized COVID-19 Patients (BioSpace)
