Monoclonal antibodies approved

Do they prevent corona infection? Monoclonal antibodies are to be used in contact persons of COVID-19 infected people to prevent infection or the outbreak of COVID-19. The European Commission approved two of the promising drugs last Friday.

The special antibodies are intended to prevent the dangerous spread of  SARS-CoV-2  in the body. As a result, they can also reduce the risk of serious illness.

Ronapreve and Regkirona recommended for marketing approval

The European  Medicines  Agency (EMA) had spoken out in favor of the approval of the two monoclonal antibody preparations Ronapreve and Regkirona. The European Commission approved it on Friday.

Both agents are specially developed antibodies based on special  proteins , which are intended to prevent the spike protein of the  coronavirus from docking onto  human cells.

Initial studies show that treatment with the two preparations could greatly reduce the number of hospitalizations and deaths. Another evaluation also showed that Ronapreve can reduce the likelihood of contracting COVID-19 if a contact person is already infected with Sars-CoV-2.

The study data on Ronapreve at a glance:

  • In corona patients who have not yet received oxygen, the monoclonal antibodies are intended to reduce the risk of a severe course.
  • only 11 of 1,192 infected patients had to be hospitalized (0.9 percent)
  • In the control group, which received a  placebo  , there were 40 out of 1,193 (3.4 percent)
  • 29 percent of those who came into contact with infected people developed symptoms within the next two weeks. In the test group it was 42.3 percent.

Ronapreve is intended to be used to treat COVID-19 in adults and adolescents (aged 12 and over and weighing at least 40 kilograms) if those affected do not require additional oxygen and are at risk patients. In addition, it should be administered for prevention to contact persons from the age of 12 and a minimum weight of 40 kilograms.

The numbers for Regkirona:

  • 14 of 446 high-risk patients (3.1 percent) had to be hospitalized or died.
  • In the placebo group, 11.1 percent required hospital treatment or died.

Regkirona should only be used for adult corona infected people who do not yet need oxygen and fall into the group of risk patients.

The side effects of both preparations were infusion-related reactions. The European Medicines Agency concluded that the benefits of the preparations outweigh the potential risks. Other monoclonal antibodies are already being reviewed by the EMA in a rolling review.

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