So far, no antibody drugs from the USA have been used to treat Covid-19 patients at the university clinics in Central Germany. This was the result of research by MDR AKTUELL. The university clinics in Dresden, Magdeburg and Jena announced that they had not yet received any such drug. From the University Hospital Leipzig it was said:
We only recently received the antibody drug at Leipzig University Hospital. So far there has been no use.
Kilinikum did not want to comment on the benefits of the drugs. According to information from the MDR, antibody drugs also arrived at the St. Georg Clinic in Leipzig at the end of January.
At the request of MDR AKTUELL, however, the Federal Minister of Health (BMG) announced that the delivery of the purchased monoclonal antibody-containing drugs was still being organized.
The federal government has secured a total of almost 200,000 cans (applications) and will be making them available step by step through specialized hospitals free of charge in the coming weeks.
Secret weapon against Corona?
The BMG has spent around 400 million euros on drugs that have not yet been approved. The two agents are Bamlavinimab from the US pharmaceutical company Eli Lilly and Casirivimab / Imdevimab (REGN-COV2 for short) from the US biotech company Regeneron Pharmaceuticals. Regeneron developed the drug together with the Swiss company Hoffmann-La Roche.
The monoclonal antibody drugs are considered to be a great glimmer of hope in the treatment of Covid sufferers with mild or mild symptoms but a high risk of severe courses.
The antibodies against the Sars coronavirus-2 produced with the help of genetic engineering can, according to current knowledge, neutralize the virus at an early stage of the infection and thus quickly cure a corona disease. They attach to the spike proteins of the coronavirus and thus prevent the virus from infecting further cells. Monoclonal antibodies therefore work before the sick come to clinics. Therefore, the drug must be administered primarily on an outpatient basis. This is difficult, however, since the administration currently takes place via an intravenous injection lasting around one hour and can therefore only be carried out in clinics. The cost per dose is around 2,000 euros.
EMA check is still ongoing
The European Medicines Agency (EMA) has been testing REGN-COV2, which is based on the two antibodies casirivimab and imdevimab, in a so-called rolling review process since the beginning of the month. Experts evaluate data from studies, even if they have not yet been completed and no application for approval has yet been submitted. The approval process can thus be shortened. The EMA confirmed to MDR AKTUELL that Regeneron has not yet applied for approval for the European market.
So far, the drug has only had an emergency approval in the USA. Ex-US President Donald Trump was treated with Regeneron during his corona illness.
The lack of data makes medical professionals skeptical
The decision as to whether monoclonal antibodies are used in German patients is currently the responsibility of the treating physicians. According to the Federal Ministry of Health, the application should take place after an individual risk-benefit assessment.
From medical circles cautious to critical voices can be heard. For example, the director of the Institute for Tropical Medicine at the Tübingen University Clinic, Peter Kremser, was amazed at the use of REGN-COV2 in an ARD Extra on the corona situation at the end of January. The data that are currently available on the drug are not conclusive either on safety, tolerability, and certainly not on effectiveness. He will certainly not use the drug. The drug commission of the German medical profession also warned against the use of unapproved drugs and drew attention to unresolved liability issues.
But there is also encouragement. The biochemist Patrick Cramer from the Max Planck Institute for Biophysical Chemistry told ZDF: “Monoclonal antibodies have been used as drugs for many years, the technology is fundamentally mature.” Buying monoclonal antibody drugs is a sensible option in the fight against corona.