Paul-Ehrlich-Institut

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CHMP Rec­om­mends Au­tho­ri­sa­tion of the SARS-CoV-2 Neu­tral­is­ing Mon­o­clon­al An­ti­body Com­bi­na­tion Evusheld (Tix­agevimab and Cil­gav­imab) for COVID-19 Therapy

The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) recommended Evusheld (tixagevimab and cilgavimab) to the European Commission on 24 March 2022. The applicant for authorisation is the company AstraZeneca AB. The two antibodies contained in Evusheld are both SARS-CoV-2 neutralising antibodies. The final decision on authorisation is taken by the European Commission.

Symbolic image Doctor forms an antibody model between his hands (Source:paulita/Shutterstock.com)

The Committee for Medicinal Products for Human Use recommends the authorisation of Evusheld for the prevention of COVID-19 in adults, adolescents, and children aged 12 years and older and weighing at least 40 kg before any potential exposure to the SARS-CoV-2 coronavirus.

Evusheld consists of the active substances tixagevimab and cilgavimab, two neutralising monoclonal antibodies that bind to two different sites of the spike protein of the SARS-CoV-2 virus. This prevents the virus from penetrating into human cells and multiplying.

The CHMP drew its conclusion after evaluating data from a clinical trial with over 5,000 participants. In the trial, Evusheld was administered as two injections of 150 mg tixagevimab and 150 mg cilgavimab. Treatment with Evusheld reduced the risk of SARS-CoV-2 infection by 77 percent. The duration of infection protection by the administration of antibodies is estimated to be at least six months.

In the study, adults who had not previously contracted COVID-19 and had received neither a COVID-19 vaccine nor another form of preventive treatment received Evusheld or a placebo (a dummy injection). Of the subjects who were administered Evusheld, 0.2% (8 out of 3,441) experienced a confirmed SARS-CoV-2 infection in the first six months after treatment, compared with 1.0% (17 out of 1,731) in the placebo group.

The safety profile of Evusheld was favourable in the study and adverse events were generally mild. A small number of patients reported injection site reactions or hypersensitivity reactions. The CHMP decided that the benefits of the medicine are greater than its risks when used as authorised.

The clinical trial data was collected before the emergence of the Omicron variant of the SARS-CoV-2 coronavirus, which currently dominates new cases in Germany. Laboratory studies show that the Omicron-BA.1 variant may be less sensitive to tixagevimab and cilgavimab at a dose of 150 mg than the original virus or Omicron BA.2 variant, which is currently the predominant variant in Europe.

The CHMP will continuously evaluate data in the coming weeks to assess whether an alternative dosing regimen might be appropriate for the prevention of COVID-19 based on emerging variants.

The final decision on authorisation is made by the European Commission and is then applied in all EU Member States.

Evusheld Already Available in Germany

The Federal Ministry of Health (BMG) began providing limited quotas of the drug Evusheld (tixagevimab/cilgavimab) for the prophylaxis of COVID-19 in mid-February 2022 for certain groups of people within the framework of the Supply Assurance for Medical Needs Ordinance (Medizinischer Bedarf Versorgungssicherstellungs­verordnung, MedBVSV). See further information.

Updated: 25.03.2022