Corona pandemic: EMA approves two Covid drugs

Status: 11.11.2021 6:56 p.m.

The EU authority EMA has given the green light for two antibody therapies for Covid-19 patients. Both drugs are intended to be used in the early stages of infection. Further approvals could follow by the end of the year.

Hope for Covid patients: The European Medicines Agency EMA has cleared the way for the approval of two new drugs against Covid-19. It is about the antibody therapy Ronapreve from the Swiss pharmaceutical company Roche and the US company Regeneron as well as the drug Regkirona (Regdanvimab) from the manufacturer Celltrion from South Korea. This was announced by the EMA in Amsterdam.

Synthetic antibodies are given directly

Both drugs are intended to be used in the early stages of infection and are based on antiviral monoclonal antibodies. These are Y-shaped proteins that attach to the spines on the surface of the coronavirus and thus prevent the pathogen from penetrating into human cells. Vaccines train the immune system to produce such antibodies as well.

However, some people, including the elderly and the immunocompromised, do not respond well to vaccines. These groups benefit most from “passive vaccination”, in which synthetic antibodies are administered directly. The Regkirona remedy is intended to treat adults who are sick with Covid-19 but do not yet need oxygen. Ronapreve should be able to be given to people from the age of twelve who are infected with the coronavirus and are at high risk of a severe course.

“Promising therapies in development”

The EMA experts had checked and evaluated all the manufacturer’s data from studies on the effectiveness and possible side effects of the agents. After the positive recommendation, the EU Commission must make the final decision. But that is a matter of form. So far, only one drug for the treatment of Covid 19 patients has been approved in the EU.

The approval is an “important stage”, said EU Health Commissioner Stella Kyriakides. In view of the increase in corona infections in almost all member states, it is “reassuring that many promising therapies are being developed as part of our treatment strategy for Covid-19”. The aim is to have up to five new treatments approved in the EU by the end of the year.

Antibody cocktail for Trump

The US Food and Drug Administration (FDA) granted emergency approval for antibody treatment from Regeneron / Roche a year ago. The then US President Donald Trump was also treated with the antibody cocktail in October last year after his corona infection. In Germany, an antibody combination that is similar to that of Ronapreve is already used in special cases for corona patients.

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