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Casirivimab/imdevimab, sold under the brand name REGEN‑COV among others, Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. is a combination
medicine Medicine is the science and practice of caring for a patient, managing the diagnosis, prognosis, prevention, treatment, palliation of their injury or disease, and promoting their health. Medicine encompasses a variety of health care practice ...
used for the treatment and prevention of
COVID19 Coronavirus disease 2019 (COVID-19) is a contagious disease caused by a virus, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The first known case was identified in Wuhan, China, in December 2019. The disease quickly ...
. It consists of two human monoclonal antibodies, casirivimab and imdevimab that must be mixed together and administered as an infusion or subcutaneous injection. The combination of two antibodies is intended to prevent mutational escape. It is also available as a co-formulated product. It was developed by the American biotechnology company
Regeneron Pharmaceuticals Regeneron Pharmaceuticals, Inc. is an American biotechnology company headquartered in Westchester County, New York. The company was founded in 1988. Originally focused on neurotrophic factors and their regenerative capabilities, giving rise to i ...
. The most common side effects include allergic reactions, which include infusion related reactions, injection site reactions, brief pain, weakness and others. The combination is approved under the brand name Ronapreve for medical use in Japan, the United Kingdom, the European Union, and Australia. In January 2022, the U.S.
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...
(FDA) revised the authorizations for two monoclonal antibody treatments –
bamlanivimab/etesevimab Bamlanivimab/etesevimab is a combination of two monoclonal antibodies, bamlanivimab and etesevimab, administered together via intravenous infusion as a treatment for COVID-19. Both types of antibody target the surface spike protein of SARS� ...
(administered together) and casirivimab/imdevimab – to limit their use to only when the recipients are likely to have been infected with or exposed to a variant that is susceptible to these treatments because data show these treatments are highly unlikely to be active against the
omicron variant Omicron (B.1.1.529) is a variant of SARS-CoV-2 first reported to the World Health Organization (WHO) by the Network for Genomics Surveillance in South Africa on 24 November 2021. It was first detected in Botswana and has spread to become the ...
.


Medical uses

In the European Union, the combination is
indicated In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis ...
for the treatment of COVID19 in people aged twelve years of age and older weighing at least who do not require supplemental oxygen and who are at high increased risk of progressing to severe COVID19; and for the prevention of COVID19 in people aged twelve years of age and older weighing at least .


Deployment

REGEN‑COV is manufactured at the Regeneron's manufacturing facility in
Rensselaer, New York Rensselaer is a city in Rensselaer County, New York, United States, and is located on the east side of the Hudson River, directly opposite of Albany. As of the 2020 census, the city population was 9,210. Rensselaer is on the western border of ...
. In September 2020, to free up manufacturing capacity for REGEN‑COV, Regeneron began to shift production of its existing products from Rensselaer to the Irish city of
Limerick Limerick ( ; ga, Luimneach ) is a western city in Ireland situated within County Limerick. It is in the province of Munster and is located in the Mid-West which comprises part of the Southern Region. With a population of 94,192 at the 2016 ...
. Regeneron has a deal in place with
Roche F. Hoffmann-La Roche AG, commonly known as Roche, is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has shares listed on the SIX S ...
(
Genentech Genentech, Inc., is an American biotechnology corporation headquartered in South San Francisco, California. It became an independent subsidiary of Roche in 2009. Genentech Research and Early Development operates as an independent center within ...
) to manufacture and market REGEN‑COV outside the United States.


Society and culture

On 2 October 2020, Regeneron Pharmaceuticals announced that then-
US President The president of the United States (POTUS) is the head of state and head of government of the United States of America. The president directs the executive branch of the federal government and is the commander-in-chief of the United States ...
Donald Trump Donald John Trump (born June 14, 1946) is an American politician, media personality, and businessman who served as the 45th president of the United States from 2017 to 2021. Trump graduated from the Wharton School of the University of P ...
had received "a single 8 gram dose of REGN-COV2" after testing positive for SARS-CoV-2. The drug was provided by the company in response to a "
compassionate use Expanded access or compassionate use is the use of an unapproved drug or medical device under special forms of investigational new drug applications (IND) or IDE application for devices, outside of a clinical trial, by people with serious or life ...
" (temporary authorization for use) request from the president's physicians. In August 2021,
Texas Governor The governor of Texas heads the state government of Texas. The governor is the leader of the executive and legislative branch of the state government and is the commander in chief of the Texas Military. The current governor is Greg Abbott, who ...
Greg Abbott Gregory Wayne Abbott (born November 13, 1957) is an American politician, attorney, and former jurist serving as the 48th governor of Texas since 2015. A member of the Republican Party, he served as the 50th attorney general of Texas from 2002 ...
received REGEN‑COV after testing positive for COVID19.


Economics

On 12 January 2021, the United States agreed to purchase 1.25 million doses of the drug for $2.625 billion, at $2,100 per dose. On 14 September, another 1.4 million doses were purchased for the same price, totaling $2.94 billion. On 24 January, the German government purchased 200,000 doses for €400 million at €2,000 per dose. On 25 May, Roche India and Cipla announced that the medicine would be available in India for Rs 59,750 per dose. On 24 September, the World Health Organization urged producers and governments to address the drug's high cost and called for technology sharing to enable the manufacture of biosimilar versions. The WHO also said that
Unitaid Unitaid is a global health initiative that works with partners to bring about innovations to prevent, diagnose and treat major diseases in low- and middle-income countries, with an emphasis on tuberculosis, malaria, and HIV/AIDS and its deadly co ...
is negotiating with Roche for lower prices and equitable distribution, especially in low- and middle income countries.


Legal status

In November 2021, the
Committee for Medicinal Products for Human Use The Committee for Medicinal Products for Human Use (CHMP), formerly known as Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee A committee or commission is a body of one or more persons subordina ...
(CHMP) of the
European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or Euro ...
(EMA) recommended granting a marketing authorization in the European Union for casirivimab/imdevimab (Ronapreve) for the treatment and prevention of COVID19. The company that applied for authorization of Ronapreve is Roche Registration GmbH. Casirivimab/imdevimab was approved for medical use in the European Union in November 2021.


Research


COVID-19

On 21 November 2020, the U.S.
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...
(FDA) issued an
emergency use authorization An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, includ ...
(EUA) for casirivimab and imdevimab to be administered together for the treatment of mild to moderate OVID19in people twelve years of age or older weighing at least with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID19. This includes those who are 65 years of age or older or who have certain chronic medical conditions. Casirivimab and imdevimab must be administered together by intravenous (IV) infusion or subcutaneous injection. Casirivimab and imdevimab are not authorized for people who are hospitalized due to COVID19 or require oxygen therapy due to COVID19. A benefit of casirivimab and imdevimab treatment has not been shown in people hospitalized due to COVID19. Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized people with COVID19 requiring high flow oxygen or mechanical ventilation. In June 2021, the EUA was revised to authorize "the use of the unapproved product, REGEN‑COV (casirivimab and imdevimab) co-formulated product and REGEN‑COV (casirivimab and imdevimab) supplied as individual vials to be administered together, for the treatment of mild to moderate COVID19 in people aged twelve years of age and older weighing at least with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID19, including hospitalization or death." The EUA was issued to Regeneron Pharmaceuticals Inc. On 1 February 2021, the
Committee for Medicinal Products for Human Use The Committee for Medicinal Products for Human Use (CHMP), formerly known as Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee A committee or commission is a body of one or more persons subordina ...
(CHMP) of the
European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or Euro ...
(EMA) started a rolling review of data on the REGN‑COV2 antibody combination (casirivimab/imdevimab), which is being co-developed by Regeneron Pharmaceuticals, Inc. and F. Hoffman-La Roche, Ltd (Roche) for the treatment and prevention of COVID19. In February 2021, the CHMP concluded that the combination, also known as REGN-COV2, can be used for the treatment of confirmed COVID19 in people who do not require supplemental oxygen and who are at high risk of progressing to severe COVID19. The Central Drugs Standards Control Organisation (CDSCO) in India, on 5 May 2021, granted an Emergency Use Authorization to
Roche F. Hoffmann-La Roche AG, commonly known as Roche, is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has shares listed on the SIX S ...
(
Genentech Genentech, Inc., is an American biotechnology corporation headquartered in South San Francisco, California. It became an independent subsidiary of Roche in 2009. Genentech Research and Early Development operates as an independent center within ...
) and
Regeneron Regeneron Pharmaceuticals, Inc. is an American biotechnology company headquartered in Westchester County, New York. The company was founded in 1988. Originally focused on neurotrophic factors and their regenerative capabilities, giving rise to i ...
for use of the casirivimab/imdevimab cocktail in the country. The announcement came in light of the second wave of the COVID19 pandemic in India. Roche India maintains partnership with
Cipla Cipla Limited (stylized as Cipla) is an Indian multinational pharmaceutical company, headquartered in Mumbai. Cipla primarily develops medicines to treat respiratory disease, cardiovascular disease, arthritis, diabetes, depression and many oth ...
, thereby permitting the latter to market the drug in the country. In July 2021, the U.S. FDA revised the emergency use authorization (EUA) for REGEN‑COV (casirivimab and imdevimab, administered together) authorizing REGEN‑COV for emergency use as post-exposure prophylaxis (prevention) for COVID19 in people aged twelve years of age and older weighing at least who are at high risk for progression to severe COVID19, including hospitalization or death. REGEN‑COV remains authorized for the treatment of mild-to-moderate COVID19 in people aged twelve years of age and older weighing at least with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID19, including hospitalization or death. On 12 April 2021,
Roche F. Hoffmann-La Roche AG, commonly known as Roche, is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has shares listed on the SIX S ...
(
Genentech Genentech, Inc., is an American biotechnology corporation headquartered in South San Francisco, California. It became an independent subsidiary of Roche in 2009. Genentech Research and Early Development operates as an independent center within ...
) and
Regeneron Regeneron Pharmaceuticals, Inc. is an American biotechnology company headquartered in Westchester County, New York. The company was founded in 1988. Originally focused on neurotrophic factors and their regenerative capabilities, giving rise to i ...
announced that the Phase III
clinical trial Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...
REGN-COV 2069 met both primary and secondary endpoints, reducing risk of infection by 81% for the non-infected participants, and reducing time-to-resolution of symptoms for symptomatic participants to one week vs. three weeks in the placebo group. In June 2021, preliminary results form the Recovery trial showed reduced mortality from 30% to 24% in people that had produced no antibodies themselves which were 33% of the total of participants.


Trials

In a clinical trial of people with COVID19, casirivimab and imdevimab, administered together, were shown to reduce COVID19-related hospitalization or emergency room visits in people at high risk for disease progression within 28 days after treatment when compared to placebo. The safety and effectiveness of this investigational therapy for use in the treatment of COVID19 continues to be evaluated. The data supporting the emergency use authorization (EUA) for casirivimab and imdevimab are based on a
randomized In common usage, randomness is the apparent or actual lack of pattern or predictability in events. A random sequence of events, symbols or steps often has no order and does not follow an intelligible pattern or combination. Individual ran ...
,
double-blind In a blind or blinded experiment, information which may influence the participants of the experiment is withheld until after the experiment is complete. Good blinding can reduce or eliminate experimental biases that arise from a participants' expec ...
,
placebo-controlled Placebo-controlled studies are a way of testing a medical therapy in which, in addition to a group of subjects that receives the treatment to be evaluated, a separate control group receives a sham "placebo" treatment which is specifically designe ...
clinical trial Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...
in 799 non-hospitalized adults with mild to moderate COVID19 symptoms. Of these participants, 266 received a single intravenous infusion of 2,400 milligrams casirivimab and imdevimab (1,200 mg of each), 267 received 8,000 mg casirivimab and imdevimab (4,000 mg of each), and 266 received a placebo, within three days of obtaining a positive SARS-CoV-2 viral test. The prespecified primary endpoint for the trial was time-weighted average change in
viral load Viral load, also known as viral burden, is a numerical expression of the quantity of virus in a given volume of fluid, including biological and environmental specimens. It is not to be confused with viral titre or viral titer, which depends on the ...
from baseline. Viral load reduction in participants treated with casirivimab and imdevimab was larger than in participants treated with placebo at day seven. However, the most important evidence that casirivimab and imdevimab administered together may be effective came from the predefined secondary endpoint of medically attended visits related to COVID19, particularly hospitalizations and emergency room visits within 28 days after treatment. For participants at high risk for disease progression, hospitalizations and emergency room visits occurred in 3% of casirivimab and imdevimab-treated participants on average compared to 9% in placebo-treated participants. The effects on viral load, reduction in hospitalizations and ER visits were similar in participants receiving either of the two casirivimab and imdevimab doses. As of September 2020, REGEN‑COV is being evaluated as part of the
Recovery Trial The Randomised Evaluation of COVID-19 Therapy (RECOVERY Trial) is a large-enrollment clinical trial of possible treatments for people in the United Kingdom admitted to hospital with severe COVID-19 infection. The trial was later expanded to In ...
, and in June 2021 the first results of the
research Research is " creative and systematic work undertaken to increase the stock of knowledge". It involves the collection, organization and analysis of evidence to increase understanding of a topic, characterized by a particular attentiveness ...
were announced with evidence proving the effectiveness of the treatment.


References


Further reading

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External links

* * * * * * * {{DEFAULTSORT:Casirivimab Imdevimab Combination antiviral drugs COVID-19 drug development Monoclonal antibodies Regeneron Pharmaceuticals Roche