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European countries await the “green light” from the Old Continent Medicines Organization (EMA) for the use of monoclonal antibodies (and) in European patients with COVID-19 infection. However, these are high-cost drugs (their price ranges between 1,000 and 1,200 euros), which if they receive the corresponding approval will be included in our national protocol.
“These are organic products, so a centralized process must be followed. The first step is to receive approval from Coreper, as the European Organization has announced that the evaluation will be done at an accelerated pace once the relevant files are submitted “, underlines the president of the Hellenic Medicines Agency (EOF), Dimitris Filippou, in “NEA”, clarifying that at least for the moment the processes are in the exploratory stage.
Meanwhile, and according to him, a file has already been submitted to the OAS – which is under investigation – for the inclusion of Greece in an international study. Therefore, if the corresponding application is accepted, Greek patients are expected to receive treatment soon as part of their inclusion in the corresponding clinical trial.
In particular, and according to the information, the international study carried out under the coordination of the National Institute of Allergy and Infectious Diseases (NIAID) of the USA refers to the investigation of the efficacy and safety of another treatment with monoclonal antibodies, with Greece contributing to the discovery of new “weapons”. »Against infection caused by the pandemic virus.
The subject of monoclonal antibodies was recently raised by Professor of Pediatric Infectious Diseases and Expert Committee member Vana Papaevangelou, highlighting that “it seems that they will also be included in our treatment protocols and will significantly improve the outcome of our patients.”
Innovative drugs
It is recalled that the innovative drugs against COVID-19 from the US pharmaceutical companies Eli-Lilly and Regeneron have recently received emergency authorization from the US Food and Drug Administration (FDA). In fact, one of the two, and in particular the REGN-COV2 preparation, is the antibody cocktail that was given to the President of the United States, Donald Trump, when he contracted the pandemic virus.
Monoclonal antibodies are laboratory proteins that mimic the action of the immune system when fighting harmful pathogens such as viruses. Therefore, in this case they are so “programmed” to specifically target the SARS-CoV-2 pin protein to prevent the virus from attaching itself to and entering human cells.
The treatment
Regarding its administration, it is indicated for the treatment of mild to moderate disease with COVID-19, in people who are confirmed positive for the SARS-CoV-2 virus and are at risk of developing a more serious disease. Therefore, according to the emergency permit they have received from the US authorities, people aged 65 years and over are included, as well as patients with chronic diseases, which are therefore more prone to serious complications.
In these circumstances, scientists hope that monoclonal antibodies will work as a “relief” for health systems around the world, which are under unprecedented pressure. Therefore, according to the relevant instructions, they should be taken as soon as possible after the onset of symptoms (within 10 days).
However, although they are administered by intravenous infusion in a hospital but in outpatients with coronavirus, they need to be monitored at home after receiving treatment.
Therefore, in the event that they receive the corresponding approval in Europe, their disposal will be made exclusively through the state “channel” and only at the request of a doctor in a public structure that will be in charge of monitoring the patient.
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