What do we know about the Regeneron cocktail for COVID-19?
What do we know about the Regeneron cocktail for COVID-19?
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Regeneron Pharmaceuticals, Inc., an American biotechnology company, recently received Emergency Use Authorization (EUA) for its COVID-19 antibody cocktail treatment of casirivimab and imdevimab by the United States. The treatment formerly known as REGN-COV2 is the first combination therapy to receive an EUA and can be used to treat mild to moderate cases of COVID-19 in recently diagnosed patients at high risk for severe cases of the virus and/or hospitalization. The treatment can also be used in pediatric patients at least 12 years of age and weighing at least 88.2 pounds or 40kg. It is an experimental drug that is designed to help the body prevent and fight off the virus. The drug is called a 'cocktail' because it mixes a combination of drugs so that it can be more effective and in this case, prevent the virus from becoming resistant to the treatment. This particular drug from Regeneron uses a combination of two "monoclonal antibodies," casirivimab and imdevimab. Antibodies are part of the immune system, and they help fight off infections and foreign invaders like COVID-19 by finding the virus, neutralizing it, and telling the rest of the immune system to begin launching its response. Monoclonal antibodies (which means 'one type of antibody') are antibodies created in a lab that can act as a replacement for the antibodies the body normally creates. These lab-made antibodies are different than the ones that the immune system creates naturally because they're uniquely designed to target and launch an attack against the specific the virus that causes COVID-19. Regeneron believes that individual antibody therapies are likely not strong enough to fight the virus that causes COVID-19, so they have combined two separate antibody treatments into one as a weapon to fight against the virus and prevent any drug resistance that might occur if they virus mutates and escapes the effects of the antibodies (called "viral escape"). Casirivimab and imdevimab are the two monoclonal antibodies in this cocktail which aims to help patients who were recently diagnosed with COVID-19 but have not yet launched their full immune system response, or who have a lot of the virus circulating in their blood. Additionally, this treatment is not authorized for use in people who are hospitalized or who need oxygen; just those with mild to moderate cases who recently tested positive for COVID-19. Regeneron also recently announced that people who received its antibody treatment had a lower number of medical visits for COVID-19 related causes in comparison to those who did not receive the treatment. Patients who received the antibody treatment made roughly 57% fewer visits to seek medical care than patients who received a placebo. In patients at high risk for serious complications from the virus (like those over 50 and people with cardiovascular or lung conditions), the reduction in visits was 72% lower than the group who did not receive the drug. Patients who were given the treatment also demonstrated lower levels of the virus in their blood and less severe symptoms than patients who did not receive the treatment. Though Regeneron's monoclonal antibody treatment has received an EUA, that authorization is only temporary so the cocktail therapy will continue to be evaluated in phase 2 and 3 clinical trials, according to the company. As of November 24, 2020, more than 7,000 people have participated in Regeneron's casirivimab and imdevimab clinical trials. The United States' government began distributing the treatment on November 24, 2020 starting with 30,000 treatment courses and expects to produce enough of the therapy to reach 80,000 patients by the end of November 2020. Regeneron's antibody cocktail is part of the United States' Operation Warp Speed and has received more than $500 million from the government to develop these treatments. This public–private partnership's goal is to create and distribution vaccines, therapies, and diagnostics for COVID-19 rapidly and safely and involves various government agencies and companies.
Regeneron Pharmaceuticals, Inc., an American biotechnology company, recently received Emergency Use Authorization (EUA) for its COVID-19 antibody cocktail treatment of casirivimab and imdevimab by the United States. The treatment formerly known as REGN-COV2 is the first combination therapy to receive an EUA and can be used to treat mild to moderate cases of COVID-19 in recently diagnosed patients at high risk for severe cases of the virus and/or hospitalization. The treatment can also be used in pediatric patients at least 12 years of age and weighing at least 88.2 pounds or 40kg. It is an experimental drug that is designed to help the body prevent and fight off the virus. The drug is called a 'cocktail' because it mixes a combination of drugs so that it can be more effective and in this case, prevent the virus from becoming resistant to the treatment. This particular drug from Regeneron uses a combination of two "monoclonal antibodies," casirivimab and imdevimab. Antibodies are part of the immune system, and they help fight off infections and foreign invaders like COVID-19 by finding the virus, neutralizing it, and telling the rest of the immune system to begin launching its response. Monoclonal antibodies (which means 'one type of antibody') are antibodies created in a lab that can act as a replacement for the antibodies the body normally creates. These lab-made antibodies are different than the ones that the immune system creates naturally because they're uniquely designed to target and launch an attack against the specific the virus that causes COVID-19. Regeneron believes that individual antibody therapies are likely not strong enough to fight the virus that causes COVID-19, so they have combined two separate antibody treatments into one as a weapon to fight against the virus and prevent any drug resistance that might occur if they virus mutates and escapes the effects of the antibodies (called "viral escape"). Casirivimab and imdevimab are the two monoclonal antibodies in this cocktail which aims to help patients who were recently diagnosed with COVID-19 but have not yet launched their full immune system response, or who have a lot of the virus circulating in their blood. Additionally, this treatment is not authorized for use in people who are hospitalized or who need oxygen; just those with mild to moderate cases who recently tested positive for COVID-19. Regeneron also recently announced that people who received its antibody treatment had a lower number of medical visits for COVID-19 related causes in comparison to those who did not receive the treatment. Patients who received the antibody treatment made roughly 57% fewer visits to seek medical care than patients who received a placebo. In patients at high risk for serious complications from the virus (like those over 50 and people with cardiovascular or lung conditions), the reduction in visits was 72% lower than the group who did not receive the drug. Patients who were given the treatment also demonstrated lower levels of the virus in their blood and less severe symptoms than patients who did not receive the treatment. Though Regeneron's monoclonal antibody treatment has received an EUA, that authorization is only temporary so the cocktail therapy will continue to be evaluated in phase 2 and 3 clinical trials, according to the company. As of November 24, 2020, more than 7,000 people have participated in Regeneron's casirivimab and imdevimab clinical trials. The United States' government began distributing the treatment on November 24, 2020 starting with 30,000 treatment courses and expects to produce enough of the therapy to reach 80,000 patients by the end of November 2020. Regeneron's antibody cocktail is part of the United States' Operation Warp Speed and has received more than $500 million from the government to develop these treatments. This public–private partnership's goal is to create and distribution vaccines, therapies, and diagnostics for COVID-19 rapidly and safely and involves various government agencies and companies.
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What our experts say
Regeneron Pharmaceuticals, Inc., an American biotechnology company, recently received Emergency Use Authorization (EUA) for its COVID-19 antibody cocktail treatment of casirivimab and imdevimab by the United States.
The treatment formerly known as REGN-COV2 is the first combination therapy to receive an EUA and can be used to treat mild to moderate cases of COVID-19 in recently diagnosed patients at high risk for severe cases of the virus and/or hospitalization. The treatment can also be used in pediatric patients at least 12 years of age and weighing at least 88.2 pounds or 40kg. It is an experimental drug that is designed to help the body prevent and fight off the virus.
The drug is called a 'cocktail' because it mixes a combination of drugs so that it can be more effective and in this case, prevent the virus from becoming resistant to the treatment. This particular drug from Regeneron uses a combination of two "monoclonal antibodies," casirivimab and imdevimab.
Antibodies are part of the immune system, and they help fight off infections and foreign invaders like COVID-19 by finding the virus, neutralizing it, and telling the rest of the immune system to begin launching its response. Monoclonal antibodies (which means 'one type of antibody') are antibodies created in a lab that can act as a replacement for the antibodies the body normally creates.
These lab-made antibodies are different than the ones that the immune system creates naturally because they're uniquely designed to target and launch an attack against the specific the virus that causes COVID-19.
Regeneron believes that individual antibody therapies are likely not strong enough to fight the virus that causes COVID-19, so they have combined two separate antibody treatments into one as a weapon to fight against the virus and prevent any drug resistance that might occur if they virus mutates and escapes the effects of the antibodies (called "viral escape").
Casirivimab and imdevimab are the two monoclonal antibodies in this cocktail which aims to help patients who were recently diagnosed with COVID-19 but have not yet launched their full immune system response, or who have a lot of the virus circulating in their blood. Additionally, this treatment is not authorized for use in people who are hospitalized or who need oxygen; just those with mild to moderate cases who recently tested positive for COVID-19.
Regeneron also recently announced that people who received its antibody treatment had a lower number of medical visits for COVID-19 related causes in comparison to those who did not receive the treatment. Patients who received the antibody treatment made roughly 57% fewer visits to seek medical care than patients who received a placebo. In patients at high risk for serious complications from the virus (like those over 50 and people with cardiovascular or lung conditions), the reduction in visits was 72% lower than the group who did not receive the drug. Patients who were given the treatment also demonstrated lower levels of the virus in their blood and less severe symptoms than patients who did not receive the treatment.
Though Regeneron's monoclonal antibody treatment has received an EUA, that authorization is only temporary so the cocktail therapy will continue to be evaluated in phase 2 and 3 clinical trials, according to the company.
As of November 24, 2020, more than 7,000 people have participated in Regeneron's casirivimab and imdevimab clinical trials. The United States' government began distributing the treatment on November 24, 2020 starting with 30,000 treatment courses and expects to produce enough of the therapy to reach 80,000 patients by the end of November 2020.
Regeneron's antibody cocktail is part of the United States' Operation Warp Speed and has received more than $500 million from the government to develop these treatments. This public–private partnership's goal is to create and distribution vaccines, therapies, and diagnostics for COVID-19 rapidly and safely and involves various government agencies and companies.
Regeneron Pharmaceuticals, Inc., an American biotechnology company, recently received Emergency Use Authorization (EUA) for its COVID-19 antibody cocktail treatment of casirivimab and imdevimab by the United States.
The treatment formerly known as REGN-COV2 is the first combination therapy to receive an EUA and can be used to treat mild to moderate cases of COVID-19 in recently diagnosed patients at high risk for severe cases of the virus and/or hospitalization. The treatment can also be used in pediatric patients at least 12 years of age and weighing at least 88.2 pounds or 40kg. It is an experimental drug that is designed to help the body prevent and fight off the virus.
The drug is called a 'cocktail' because it mixes a combination of drugs so that it can be more effective and in this case, prevent the virus from becoming resistant to the treatment. This particular drug from Regeneron uses a combination of two "monoclonal antibodies," casirivimab and imdevimab.
Antibodies are part of the immune system, and they help fight off infections and foreign invaders like COVID-19 by finding the virus, neutralizing it, and telling the rest of the immune system to begin launching its response. Monoclonal antibodies (which means 'one type of antibody') are antibodies created in a lab that can act as a replacement for the antibodies the body normally creates.
These lab-made antibodies are different than the ones that the immune system creates naturally because they're uniquely designed to target and launch an attack against the specific the virus that causes COVID-19.
Regeneron believes that individual antibody therapies are likely not strong enough to fight the virus that causes COVID-19, so they have combined two separate antibody treatments into one as a weapon to fight against the virus and prevent any drug resistance that might occur if they virus mutates and escapes the effects of the antibodies (called "viral escape").
Casirivimab and imdevimab are the two monoclonal antibodies in this cocktail which aims to help patients who were recently diagnosed with COVID-19 but have not yet launched their full immune system response, or who have a lot of the virus circulating in their blood. Additionally, this treatment is not authorized for use in people who are hospitalized or who need oxygen; just those with mild to moderate cases who recently tested positive for COVID-19.
Regeneron also recently announced that people who received its antibody treatment had a lower number of medical visits for COVID-19 related causes in comparison to those who did not receive the treatment. Patients who received the antibody treatment made roughly 57% fewer visits to seek medical care than patients who received a placebo. In patients at high risk for serious complications from the virus (like those over 50 and people with cardiovascular or lung conditions), the reduction in visits was 72% lower than the group who did not receive the drug. Patients who were given the treatment also demonstrated lower levels of the virus in their blood and less severe symptoms than patients who did not receive the treatment.
Though Regeneron's monoclonal antibody treatment has received an EUA, that authorization is only temporary so the cocktail therapy will continue to be evaluated in phase 2 and 3 clinical trials, according to the company.
As of November 24, 2020, more than 7,000 people have participated in Regeneron's casirivimab and imdevimab clinical trials. The United States' government began distributing the treatment on November 24, 2020 starting with 30,000 treatment courses and expects to produce enough of the therapy to reach 80,000 patients by the end of November 2020.
Regeneron's antibody cocktail is part of the United States' Operation Warp Speed and has received more than $500 million from the government to develop these treatments. This public–private partnership's goal is to create and distribution vaccines, therapies, and diagnostics for COVID-19 rapidly and safely and involves various government agencies and companies.
Context and background
Though the treatment had not yet received EUA from the U.S. FDA, United States President Donald Trump was administered the Regeneron experimental treatment in early October of 2020, in response to his COVID-19 diagnosis and as part of a compassionate use allowance. Since then, the company has reported early findings from its studies in order to obtain its EUA, including phase 2 data from the first 799 adults who volunteered for the trial. These outpatients participants are part of an ongoing clinical trial involving people who receive the Regeneron treatment and those who receive the placebo. Currently, the recommended dose is 1,200 mg of casirivimab and 1,200 mg of imdevimab (2,400 mg total) administered as a single treatment where the liquid medication is inserted directly into a patient's vein (called an 'intravenous infusion').
As this Regeneron treatment was partially funded by the U.S. government, the first 300,000 doses will be free to patients but they may be charged a fee for the healthcare facility providing the care. The company has begun shopping doses to a national distributor called Amerisource Bergen who will dispense the treatment as the U.S. federal government directs them.
Though the treatment had not yet received EUA from the U.S. FDA, United States President Donald Trump was administered the Regeneron experimental treatment in early October of 2020, in response to his COVID-19 diagnosis and as part of a compassionate use allowance. Since then, the company has reported early findings from its studies in order to obtain its EUA, including phase 2 data from the first 799 adults who volunteered for the trial. These outpatients participants are part of an ongoing clinical trial involving people who receive the Regeneron treatment and those who receive the placebo. Currently, the recommended dose is 1,200 mg of casirivimab and 1,200 mg of imdevimab (2,400 mg total) administered as a single treatment where the liquid medication is inserted directly into a patient's vein (called an 'intravenous infusion').
As this Regeneron treatment was partially funded by the U.S. government, the first 300,000 doses will be free to patients but they may be charged a fee for the healthcare facility providing the care. The company has begun shopping doses to a national distributor called Amerisource Bergen who will dispense the treatment as the U.S. federal government directs them.
Resources
- Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19 (ClinicalTrials.gov)
- Regeneron Seeks FDA Emergency Clearance for Covid-19 Therapy (Bloomberg)
- Regeneron's REGN-COV2 Antibody Cocktail Reduced Viral Levels and Improved Symptoms in Non-Hospitalized COVID-19 Patients (Regeneron)
- Coronavirus: Monoclonal antibodies to begin UK trial (BBC)
- Antibody cocktail to SARS-CoV-2 spike protein prevents rapid mutational escape seen with individual antibodies (Science)
- Trump is being treated with an experimental drug cocktail for COVID-19. Here's what it is (CBS)
- Antibody treatment Trump touts relied on testing with fetal tissue he opposes (Washington Post)
- Developing REGN-COV2 (Regeneron)
- Regeneron Confirms that REGN-COV2 Antibody Cocktail Provided to President Trump Under Compassionate Use Request (Regeneron)
- Compassionate Use Request (Regeneron)
- What President Trump’s ‘compassionate use’ of a Covid-19 drug means — and doesn’t mean (STAT)
- Regeneron's casirivimab and imdevimab antibody cocktail for COVID-19 is first combination therapy to receive FDA Emergency Use Authorization (Regeneron)
- Two science publications highlight potential of REGN-COV2 anti-viral antibody cocktail to protect against SARS-COV-2 escape mutants (Regeneron)
- Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 (U.S. FDA)
- F.D.A. Grants Emergency Authorization of Antibody Treatment Given to Trump (NYT)
- Regeneron says its COVID-19 antibody treatment cut medical visits in trial (Reuters)
- U.S. to begin distributing Regeneron's COVID-19 antibody therapy Tuesday (Reuters)
- Phase 3 prevention trial showed 81% reduced risk of symptomatic SARS-CoV-2 infections with subcutaneous administration of REGEN-COV™ (CASIRIVIMAB WITH IMDEVIMAB) (Regeneron Press Release)
- Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19 (ClinicalTrials.gov)
- Regeneron Seeks FDA Emergency Clearance for Covid-19 Therapy (Bloomberg)
- Regeneron's REGN-COV2 Antibody Cocktail Reduced Viral Levels and Improved Symptoms in Non-Hospitalized COVID-19 Patients (Regeneron)
- Coronavirus: Monoclonal antibodies to begin UK trial (BBC)
- Antibody cocktail to SARS-CoV-2 spike protein prevents rapid mutational escape seen with individual antibodies (Science)
- Trump is being treated with an experimental drug cocktail for COVID-19. Here's what it is (CBS)
- Antibody treatment Trump touts relied on testing with fetal tissue he opposes (Washington Post)
- Developing REGN-COV2 (Regeneron)
- Regeneron Confirms that REGN-COV2 Antibody Cocktail Provided to President Trump Under Compassionate Use Request (Regeneron)
- Compassionate Use Request (Regeneron)
- What President Trump’s ‘compassionate use’ of a Covid-19 drug means — and doesn’t mean (STAT)
- Regeneron's casirivimab and imdevimab antibody cocktail for COVID-19 is first combination therapy to receive FDA Emergency Use Authorization (Regeneron)
- Two science publications highlight potential of REGN-COV2 anti-viral antibody cocktail to protect against SARS-COV-2 escape mutants (Regeneron)
- Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 (U.S. FDA)
- F.D.A. Grants Emergency Authorization of Antibody Treatment Given to Trump (NYT)
- Regeneron says its COVID-19 antibody treatment cut medical visits in trial (Reuters)
- U.S. to begin distributing Regeneron's COVID-19 antibody therapy Tuesday (Reuters)
- Phase 3 prevention trial showed 81% reduced risk of symptomatic SARS-CoV-2 infections with subcutaneous administration of REGEN-COV™ (CASIRIVIMAB WITH IMDEVIMAB) (Regeneron Press Release)
