So far, only one drug for the treatment of Covid 19 patients has been approved in the EU.
(Photo: dpa)
Frankfurt The European Medicines Agency Ema has officially recommended two antibody therapies against Covid-19 for approval for the first time. These are the drug Ronapreve, which the Swiss pharmaceutical company Roche sells in cooperation with the US company Regeneron, and the drug Regkirona (Regdanvimab) from the manufacturer Celltrion from South Korea. The final approval decision of the EU Commission should now follow shortly.
Stella Kyriakides, EU Commissioner for Health and Food Safety, welcomed the decision as an important step towards the goal of approving five new therapeutics against Covid in the EU by the end of the year. “With Covid-19 infections increasing in almost all Member States, it is reassuring to see how many promising drugs are being developed as part of our strategy for Covid-19 therapeutics,” she said.
So far, only the antiviral drug Remdesivir from Gilead has been officially approved in the EU specifically for the treatment of Covid-19. However, its effect is considered to be moderate.
The antibody preparations, on the other hand, have shown in studies that they reduce the risk of severe disease and death by around 70 to 80 percent if they are used early enough. Ronapreve, which consists of a combination of two antibodies, also reduced the risk of disease in tests in people who had close contact with Covid patients.
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The drug, which was developed by the US biotech company Regeneron, has been approved in the USA since November 2020 as part of an emergency authorization (EUA) by the FDA under the name REGN-COV, as are similar preparations by Eli Lilly and Glaxo-Smithkline. The antibody drug has also been used in Europe for several months on the basis of national exemptions, including Germany. Regeneron posted sales of around $ 4.7 billion with the product in the first nine months of 2021, and Roche earned around $ 1.1 billion with the product.
There are great hopes for pill drugs
Antibodies are characterized by the fact that they can dock onto certain molecules very specifically. They are usually produced by the immune system in response to infection. They are able to block viruses and mark infected body cells so that they can be recognized and destroyed by immune cells. In the case of Covid-19 drugs, these are antibodies that are specifically produced in biotechnological systems based on the model of natural antibodies.
A major disadvantage of the products is that, due to their complicated molecular structure, they can only be administered as an infusion or at most as an injection. This makes mass use of these products difficult. In addition, the production is relatively complex.
Greater hopes therefore rest on new antiviral agents that can also be taken as tablets. These include the active ingredient molnupiravir from the US group Merck & Co. and, above all, the drug Paxlovid, for which Pfizer recently published very promising data.
Official approval for these active ingredients in the EU is hardly in sight before 2022. However, it seems conceivable that these products will also be able to be used prematurely on the basis of a national exemption, similar to that for the antibodies.
In the case of molnupiravir, Ema announced last week that the agency’s medical committee wanted to draw up recommendations as soon as possible in order to support national authorities in their decision-making.
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