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The use of monoclonal antibodies to treat COVID-19

  • 8 February 2021
  • ACTEMRA, application, AstraZeneca, AZD7442, bamlanivimab, benefits, casirivimab, Celltrion, CHMP, cilgavimab, CMA, conditional marketing authorisation, COVID-19, CT-P59, EC, EEA, Eli Lilly, EMA, etesevimab, EU, Evusheld, F. Hoffman-La Roche Ltd, FDA, GlaxoSmithKline, GSK4182136, imdevimab, mAb, monoclonal antibodies, regdanvimab, Regeneron Pharmaceuticals Inc., Regkirona, REGN-COV2, risks, RoActemra, Roche, rolling review, SARS-Cov-2, sotrovimab, tixagevimab, tocilizumab, Vir Biotechnology Inc., VIR-7831,

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EMA’s human medicines committee (CHMP) is reviewing available data on the use of the monoclonal antibodies casirivimab, imdevimab, bamlanivimab and etesevimab to treat patients with COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19. The committee will carry out two separate reviews, one for the casirivimab/imdevimab combination and another for bamlanivimab/etesevimab.

EMA is reviewing the data to provide a harmonised scientific opinion at EU level to support national decision making on the possible use of the antibodies before a formal authorisation is issued.

The reviews have been started in view of recent studies that looked into the effects of the combinations casirivimab/imdevimab and bamlanivimab/etesevimab in outpatients with COVID-19 who do not need supplemental oxygen. Preliminary results for both studies indicate that the combinations reduced the viral load (amount of virus in the back of the nose and throat) more than placebo (a dummy treatment) and led to fewer COVID-19-related medical visits and hospitalisations.

The Committee will also look at the use of bamlanivimab alone based on a study which indicated that bamlanivimab monotherapy can reduce viral load and provide clinical benefit.

Casirivimab, imdevimab, bamlanivimab and etesevimab are monoclonal antibodies with activity against COVID-19. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen).

These four monoclonal antibodies are designed to attach to the spike protein of SARS-CoV-2 at different sites. When they attach to the spike protein, the virus is unable to enter the body’s cells. The antibodies attach to different parts of the protein and using them in combination (casirivimab with imdevimab and bamlanivimab with etesevimab) may have a greater effect than using them alone.


 
 
MAB

casirivimab/imdevimab Ronapreve (REGN-COV2)

Regeneron Pharmaceuticals Inc. & F. Hoffman-La Roche Ltd

 
EMA 
  • Authorised

Marketing authorisation (MA)
Date of issue: 2021-11-12



Update [26/02/2021]

EMA’s human medicines committee (CHMP) has completed its review on the use of the monoclonal antibodies casirivimab and imdevimab to treat patients with COVID-19. This review was undertaken to provide a harmonised scientific opinion at EU level to support national decision making on the possible use of the antibodies prior to marketing authorisation. The Agency concluded that the combination also known as REGN-COV2 can be used for the treatment of confirmed COVID-19 in patients who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19.

The medicine is given by infusion (drip) into a vein and the proposed conditions of use are available here.

EMA made its recommendations following review of data including quality data and a study that looked into the effects of the combination in outpatients with COVID-19 who do not need supplemental oxygen. Preliminary results indicate that the combination reduced the viral load (amount of virus in the back of the nose and throat) more than placebo (a dummy treatment) and led to fewer COVID-19-related medical visits.

In terms of safety, most side effects reported were mild or moderate, however reactions related to the infusion (including allergic reactions) have been seen and should be monitored for.

EMA’s recommendations can now be used to support national advice on the possible use of the antibodies before a marketing authorisation is issued.

In parallel, a rolling review of the combination of antibodies casirivimab and imdevimab, which started on 1st February, is currently ongoing. Once finalised it will be the basis for an EU marketing authorisation for this combination.

 

EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on a medicine known as 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 COVID-19.

The CHMP’s decision to start the rolling review is based on preliminary results from a study that indicate a beneficial effect of the medicine in reducing the amount of virus in the nose and throat of non-hospitalised patients with COVID-19.

EMA has started evaluating the first batch of data on the medicine, which come from laboratory and animal studies (non-clinical data).

The CHMP will evaluate all data on this medicine, including evidence from a study in hospitalised patients with COVID-19 and other clinical trials as they become available.

The rolling review will continue until enough evidence is available to support a formal marketing authorisation application.

 

 
FDA
  • Authorized

Emergency use authorization (EUA)
Date of issue: 2020-11-21




MAB

bamlanivimab/etesevimab

Eli Lilly & Company

 

Update [11/03/2021]

EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on the antibodies bamlanivimab and etesemivab which are being developed by Eli Lilly to be used in combination for the treatment of COVID-19. The review will also look at bamlanivimab used alone.

The decision to start the rolling review is based on preliminary results from two studies, one looking at the ability of the medicines to treat COVID-19 when combined, the other one when bamlanivimab is used alone. However, EMA has not yet evaluated the full dataset and it is too early to draw any conclusions regarding the benefit-risk balance of the medicines.

EMA has started evaluating the first batch of data, which come from animal studies (non-clinical data).

EMA will evaluate all data on these medicines, including evidence from clinical trials as they become available. The rolling review will continue until enough evidence is available to support formal marketing authorisation applications.

EMA will assess the medicine’s compliance with the usual standards for effectiveness, safety and quality. While the overall review timeline cannot be forecast yet, the process should be quicker than a regular evaluation due to the time gained during the rolling review.

 

Update [08/03/2021]

EMA’s human medicines committee (CHMP) has completed its review on the use of the monoclonal antibodies bamlanivimab and etesevimab to treat patients with COVID-19. This review was undertaken to provide a harmonised scientific opinion at EU level to support national decision making on the possible use of the antibodies prior to marketing authorisation.

The Agency concluded that bamlanivimab and etesevimab can be used together to treat confirmed COVID-19 in patients who do not require supplemental oxygen and who are at high risk of their COVID-19 disease becoming severe. The Agency also looked at the use of bamlanivimab alone and concluded that, despite uncertainties around the benefits of monotherapy, it can be considered a treatment option.

The medicines are given by infusion (drip) into a vein and the proposed conditions of use are available here.

EMA made its recommendations following a review of data including quality data, and data from a study that looked into the effects of monotherapy and combination therapy in outpatients with COVID-19 who do not need supplemental oxygen. Although some uncertainties remain, particularly around the benefits of monotherapy, the results indicate that the combination reduced the viral load (amount of virus in the back of the nose and throat) more than placebo (a dummy treatment). The results also indicated that the combination and monotherapy led to fewer COVID-19-related medical visits.

In terms of safety, most side effects reported were mild or moderate; however, reactions related to the infusion (including allergic reactions) are likely and should be monitored for.

EMA’s recommendations can now be used to support national advice on the possible use of the antibodies before a marketing authorisation is issued.

Bamlanivimab and etesevimab are both monoclonal antibodies. A monoclonal antibody is a type of protein that has been designed to recognise and attach to a specific structure (called an antigen). Bamlanivimab and etesevimab have been designed to attach to the spike protein of SARS-CoV-2 at two different sites. When the medicines are attached to the spike protein, the virus is unable to enter the body’s cells.

 

 
FDA
  • Authorized

Emergency use authorization (EUA)
Date of issue: 2021-02-09




MAB

bamlanivimab

Eli Lilly & Company

 
FDA
Revoked
  • Authorized

Emergency use authorization (EUA)
Date of revocation:
2021-04-16

Date of issue: 2020-11-09




MAB

regdanvimab (CT-P59)

Regkirona, Celltrion

 
EMA 
  • Authorised

Marketing authorisation (MA)
Date of issue: 2021-11-12



Update [02/04/2021]

EMA’s human medicines committee (CHMP) has completed its review on the use of the monoclonal antibody regdanvimab (also known as CT-P59) to treat patients with COVID-19. This review was undertaken to provide a harmonised scientific opinion at EU level to support national decision-making on the possible use of the antibody prior to marketing authorisation. The Agency concluded that regdanvimab can be used for the treatment of confirmed COVID-19 in adult patients who do not require supplemental oxygen therapy and who are at high risk of progressing to severe COVID-19.

The medicine is given by infusion (drip) into a vein and the proposed conditions of use are available here.

EMA made its recommendations following a review of data from an ongoing study looking into the effects of regdanvimab in adult outpatients with COVID-19 symptoms described as mild to moderate who do not need supplemental oxygen. Results from the first part of the study indicate that regdanvimab may lower the rate of hospitalisation. However, the results were not robust enough to reach a firm conclusion on the medicine’s benefits at this point in time. In terms of safety, most side effects reported were mild or moderate. Reactions related to the infusion (including allergic reactions) cannot be excluded and healthcare professionals should monitor patients for these reactions.

Despite the uncertainties, the CHMP concluded that regdanvimab can be considered a treatment option for patients at high risk of progressing to severe COVID-19, based on a reasonable likelihood that the medicine may provide clinical benefit, and a low likelihood of harm.

EMA’s recommendations can now be used to support national advice on the possible use of this monoclonal antibody before a marketing authorisation is issued.

While the current evaluation has concluded, a rolling review of regdanvimab, which started on 24 February, is currently ongoing. Once finalised, the rolling review will be the basis for an EU marketing authorisation application for this medicine.

Update [09/03/2021]

EMA is conducting a review of Celltrion’s monoclonal antibody regdanvimab (CT-P59) to support national authorities who may decide on the use of this medicine for COVID-19 prior to authorisation.

This review is in addition to the ongoing rolling review of regdanvimab for the treatment of confirmed COVID-19 in patients who do not require supplemental oxygen therapy and are at high risk for progressing to severe COVID-19 and/or hospitalisation.

EMA’s human medicines committee (CHMP) will look at data on how well the medicine prevents COVID-19 from becoming severe or reduces hospitalisation and admission to intensive care units.

While the more comprehensive rolling review is ongoing ahead of a possible application for a marketing authorisation, this procedure will provide a shared EU expert opinion to national authorities who may take evidence-based decisions on early use of the medicine, e.g. in compassionate use programmes.

EMA will communicate on the outcome of this review once it concludes.

 

EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on the monoclonal antibody regdanvimab (also known as CT-P59), which is being developed by Celltrion, for the treatment of COVID-19.

The decision to start the rolling review is based on preliminary results from an ongoing study looking at the ability of the medicine to treat COVID-19. However, EMA has not yet evaluated the full dataset and it is too early to draw any conclusions regarding the benefit-risk balance of the medicine.

EMA has started evaluating the first batch of data, which come from animal studies (non-clinical data) and clinical trials, in addition to data on the quality of the medicine.

The EMA will evaluate all data on this medicine as they become available. The rolling review will continue until enough evidence is available to support a formal marketing authorisation application.

Regdanvimab is a monoclonal antibody with activity against COVID-19. A monoclonal antibody is a type of protein that has been designed to attach to a specific structure (called an antigen). Regdanvimab has been designed to attach to the spike protein of SARS-CoV-2, the virus that causes COVID-19. When it attaches to the spike protein, the ability of the virus to enter the body’s cells is reduced. This is expected to reduce the need for hospitalisation in patients with mild to moderate COVID-19.


 
 
MAB

sotrovimab
(VIR-7831, GSK4182136)

GlaxoSmithKline
and Vir Biotechnology, Inc.

 

NEW! Update [25/05/2021]

EMA’s human medicines committee (CHMP) has completed its review on the use of the monoclonal antibody sotrovimab (also known as VIR-7831 and GSK4182136) to treat patients with COVID-19. This review was undertaken to provide a harmonised scientific opinion at EU level to support national decision-making on the possible use of the antibody prior to marketing authorisation.

The Agency concluded that sotrovimab can be used to treat confirmed COVID-19 in adults and adolescents (aged 12 years and above and weighing at least 40 kg) who do not require supplemental oxygen therapy and who are at risk of progressing to severe COVID-19.

The medicine is given by infusion (drip) into a vein and the proposed conditions of use are available here.

EMA made its recommendations following a review of data, including data on quality and from a study into the effects of sotrovimab in adult outpatients with mild COVID-19 symptoms who do not need supplemental oxygen. A planned interim analysis of this study indicated that sotrovimab reduced the risk of hospitalisation for more than 24 hours or death by 85% compared with placebo: hospitalisation for more than 24 hours or death occurred in 1% (3 out of 291) of patients who received sotrovimab and 7% (21 out of 292) of those who received placebo.

In terms of safety, most side effects reported were mild or moderate. Reactions related to the infusion (including allergic reactions) cannot be excluded and healthcare professionals should monitor patients for these reactions.

EMA’s recommendations can now be used to support national advice on the possible use of this monoclonal antibody before a marketing authorisation is issued.

While the current evaluation has concluded, a rolling review of sotrovimab, which started on 7 May, is ongoing. Once finalised, the rolling review will be the basis for an EU marketing authorisation application for this medicine.

 

Update [19/05/2021]

On 7 May 2021, EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on sotrovimab (also known as VIR-7831 and GSK4182136), a monoclonal antibody developed by GlaxoSmithKline and Vir Biotechnology, Inc. for the treatment of COVID-19.

The decision to start the rolling review is based on preliminary results from an ongoing study looking at the ability of the medicine to prevent hospitalisation or death in non-hospitalised patients with COVID-19. However, EMA has not yet received the full dataset and it is too early to draw any conclusions regarding the benefit-risk balance of the medicine.

EMA has started evaluating the first batch of data, which come from laboratory and animal studies, in addition to data on the quality of the medicine.

EMA will evaluate all data on this medicine, including evidence from clinical trials, as they become available. The rolling review will continue until enough evidence is available to support a formal marketing authorisation application.

EMA will assess the medicine’s compliance with the usual EU standards for effectiveness, safety and quality. While the overall review timeline cannot be forecast yet, the process should be quicker than a regular evaluation due to the time gained during the rolling review.

A separate review of sotrovimab is already underway to provide EU-wide recommendations to support national authorities who may decide on the use of the medicine for COVID-19 prior to marketing authorisation.

 

EMA is reviewing currently available data on the use of the monoclonal antibody VIR-7831 (also known as GSK4182136) in the treatment of patients with COVID-19. EMA is starting this review to support national authorities who may decide on the use of this medicine for COVID-19 prior to marketing authorisation.

The review will include data from a study comparing the effect of VIR-7831 with that of a dummy treatment (placebo) in patients with mild to moderate COVID-19 who were at high risk of progressing to more severe COVID-19. The preliminary results indicate that VIR-7831 reduced the risk of hospitalisation for more than 24 hours or death by 85% compared with placebo.

EMA’s human medicines committee (CHMP) will look at how well the medicine prevents hospitalisation and death in non-hospitalised COVID-19 patients who do not require oxygen supplementation. The CHMP will also consider data on the medicine’s quality and safety.

While a more comprehensive rolling review is anticipated to start ahead of a possible application for a marketing authorisation, this current review will provide EU-wide recommendations for national authorities who may take evidence-based decisions on the early use of the medicine.

EMA will communicate on the outcome of this review once it concludes.

VIR-7831 (GSK4182136) is a monoclonal antibody with activity against SARS-CoV-2, the virus that causes COVID-19. A monoclonal antibody is a type of protein that attaches to a specific structure (called an antigen). VIR-7831 is designed to attach to the spike protein of SARS-CoV-2, limiting the ability of the virus to enter the body’s cells. The medicine is expected to reduce the need for hospitalisation in patients with COVID-19.

 

 
FDA
  • Authorized

Emergency use authorization (EUA)
Date of issue: 2021-05-26




MAB

tocilizumab

 
FDA
  • Authorized

Emergency use authorization (EUA)
Date of issue: 2021-06-24




MAB

tixagevimab & cilgavimab Evusheld, (AZD7442)

AstraZeneca

 
FDA
  • Authorized

Emergency use authorization (EUA)
Date of issue: 2021-12-08



 

Information on vaccines against COVID-19 you can find here.

More regulatory information on COVID-19 you can find here.

 
Source: EMA, FDA