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Two new drugs will be used to treat COVID-19 patients. It’s Ronapreve and Regkiron. It was possible thanks to the decision of the European Medicines Agency (EMA), which recommended the approval of these preparations to the market by the European Commission. In what cases will I be used? How do they work? And finally – when can we expect them in Poland?
- The Committee on Medicines for People of the European Medicines Agency on Thursday gave a positive assessment of two drugs against COVID-19: Ronapreve and Regkiron. The Agency recommended that both preparations be approved for marketing in Europe
- The Committee examined the efficacy and safety of these preparations and assessed that the benefits of the therapy with these drugs outweigh the possible risks.
- Both medicines contain monoclonal antibodies, modified proteins that mimic natural antibodies to fight viruses
- How exactly do they work and who can they be used for?
- More information can be found on the Onet homepage
EMA has approved two new anti-COVID-19 drugs
On November 11, the Committee for Medicines for Human (CHMP) of the European Medicines Agency (EMA) gave a positive assessment of two drugs against COVID-19: the aforementioned Ronapreve and Regkirona. The EMA recommended that both preparations be approved for marketing in Europe. Thus, they joined the list of products indicated in the treatment of COVID-19, which have received a positive opinion since the recommendation for the preparation containing remdesivir (in June 2020).
The approval of the two new drugs is an “important step” in the fight against the disease, stressed EU Health Commissioner Stella Kyriakides in a statement. »With the increasing number of COVID-19 infections in almost all Member States, it is reassuring to see many promising treatments (…). Today we are taking an important step towards our goal of approving up to five new therapies in the EU by the end of the year, ”wrote Kyriakides.
«The progress of the pandemic across the EU shows how fragile the situation is and how important it is that COVID-19 patients have access to safe and effective treatments. But it shows even more that we must continue the rush to vaccinate, especially in those Member States where the vaccination rate is lower. Vaccinations are the only preventive way out of the crisis »reminded the Commissioner.
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Two new drugs against COVID-19. How do they work?
But let’s go back to the new drugs against COVID-19: Ronapreve and Regkiron. It is worth noting that these are the first preparations against COVID-19 based on the so-called monoclonal antibodies that have received a positive opinion from the Committee on Medicines for Human. What are these antibodies?
Recall that antibodies are proteins produced by the body to protect the body against pathogens such as SARS-CoV-2. Monoclonal antibodies / proteins are produced under laboratory conditions and are designed to neutralize antigens (in this case SARS-CoV-2) and inhibit the multiplication of the virus in the body. In other words, they are modified proteins that mimic natural antibodies to fight viruses.
The term “monoclonal” is important here. It means that all these antibodies are the same and attack the virus in one specific place (for comparison, after vaccination, the body creates a mixture of antibodies that can attach to the virus in different places – then we are talking about polyclonal antibodies).
New COVID-19 Drugs: Ronapreve and Regkiron. For whom?
Ronapreve and Regkirona are therapies for use in the early stages of SARS-CoV-2 infection and, as the EMA notes, treatment with them “significantly reduces hospitalizations and deaths in COVID-19 patients at risk of developing severe disease”. The agency also mentions a study that showed Ronapreve reduces the risk of contracting COVID-19 when a household member is infected with the SARS-CoV-2 coronavirus.
The Committee for Medicines for the People has recommended that Ronapreve be approved for the treatment of COVID-19 in adults and adolescents (12 years of age and over and weighing at least 40 kg) who are at increased risk of a severe course of infection and who do not require oxygen therapy. The medicine is presented as a solution for injection or infusion.
The use of Regkiron (presented as a concentrate for solution for infusion) has been recommended for adult patients only, in the same situation as with Ronapreve.
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When will new COVID-19 drugs be available in Poland?
Following the announced positive assessment of the two new anti-COVID-19 drugs, the Committee for Medicinal Products for Human Use will submit recommendations for both preparations to the European Commission for a swift marketing authorization decision. When can Ronapreve and Regkirona be available to Polish patients?
– We are currently in contact with one manufacturer and we will want to buy this drug in the coming weeks – a spokesman for the Ministry of Health said in PAP. Wojciech Andrusiewicz emphasized that in the fourth wave of the epidemic there is also a new drug for use in moderate and severe COVID-19 disease. – It’s baricitinib. This drug only entered hospitals in this fourth wave of covid. It is already used at the moment, subsequent purchase tranches go to Poland. We also use tocilizumab – as in previous epidemic waves. We currently use less remdesivir – he said.
According to a spokesman for the Ministry of Health, Poland is “quite well supplied with drugs against COVID-19”.
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