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Two new weapons are added to the Medic’s Healing Quiver in battle against it. pandemic. These are the innovative drugs against COVID-19 from the American pharmaceutical companies Eli Lilly and the Regeneron from the Greek-American George Giankopoulos recently approved by the US Food and Drug Administration (FDA). REGN-COV2 is the antibody cocktail delivered to the President of the United States. Donald trump during your treatment.
These are very high cost formulations from Eli Lilly and Regeneron that are fully humanized monoclonal antibodies.. The cost of bamlanivimab is 1,000 euros per bottle of 700 mg, while the price of the REGN-COV2 cocktail in Europe, according to press reports, is set at about 1,200 euros per bottle. It should be noted that both drugs appear to be able to ease health systems by reducing the need for new patient admissions to hospitals. For this reason, they are administered by intravenous infusion in a hospital, but in outpatients with coronavirus After receiving treatment, follow-up continues at home. However, the two pharmaceutical companies are already studying alternative forms of their drugs, so that they can be administered subcutaneously, that is, by injection, to facilitate their home use.
The license
In Greece, as he first wrote “TOPIC»On Sunday, November 15, the national pharmaceutical company Pharmaserve-Lilly, which represents Eli Lilly’s products in our country, already submitted a relevant request to the National Medicines Agency (OEA) and is waiting to be able to meet Bamlanivimab’s internal demand, as soon as the OAS grants the special authorization. If the license is granted in mid-December, the company will begin deliveries of the drug in January 2021. As for the drug recommended by Regeneron for patients at high risk of severe disease, in Greece Roche has committed to inform EOF and the Ministry of Health in case additional information is requested on REGN-COV2 and its inclusion in the Greek treatment algorithm for COVID-19 infection.
As Mrs. Vana Papaevangelou, professor of Pediatric Infectious Diseases at the EKPA School of Medicine and member of the Expert Committee of the Ministry of Health, said last Monday, referring to monoclonal antibodies coronavirus, “It appears that these will also be included in our treatment protocols and will significantly improve the outcome for our patients.”
THE Regeneron has already announced that it will have REGN-COV2 vials ready for commercial use for the needs of 80,000 patients by the end of November, while by the first week of January 2021 it will be able to cover the therapeutic needs of 200,000 patients with COVID-19 infection already end of the same month 300,000 respectively.
In Europe Regeneron, in cooperation with the biopharmaceutical company Roche, is already launching a special licensing process by the European Medicines Agency (Coreper).
Monoclonal antibodies since the beginning of the pandemic had been investigated as a possible treatment for COVID-19 infection, as their use in other serious diseases has been documented to help the immune system fight infection by reducing the risk of deterioration. and finally contribute to patient.
In the case of COVID-19, doctors now have at their disposal two formulations based on monoclonal antibodies that, from clinical trials to date, reduce the probability of hospitalization while preventing the patient from deteriorating to a minimum. hospitalization in ICU.
The first drug that the FDA will obtain on November 9 from the Emergency Fuel License (USA) is the neutralizing human antibody Bamlanivimab that is being investigated by the American pharmaceutical company Eli Lilly. It is suitable for the treatment of recently diagnosed mild or intermediate COVID-19 infection, for patients at high risk of severe illness or hospitalization, from the age of 12 and weighing at least 40 kg. In fact, its administration is recommended as soon as possible from the diagnosis, that is, from the moment the COVID-19 infection is confirmed in the laboratory and definitely within 10 days from the onset of symptoms.
Evidence from BLAZE-1, a randomized, double-blind, placebo-controlled phase 2 clinical trial, shows that in patients receiving an intravenous infusion of one dose (700 mg) of Bamlanivimab, a significant reduction in viral load was observed. . illness and especially the need for hospitalization. Among the most commonly observed side effects in the study were: fever, chills, nausea, headache, injection site irritation, myalgia, and dizziness.
How much it costs and how it will be available
Its cost Bamlanivimab It is set at € 1,000 per vial and, although at first glance it is a high cost product, in reality it is not. Because, administered on time and to the right patients, the health system saves the cost of hospitalization for a patient in a single bed, that is to say about 100 euros a day, much more than the cost of daycare in bed. ICU which is around 1,700 euros a day, depending on the severity of the disease.
Furthermore, as mentioned above, the formulation in United States It has been temporarily indicated for administration to people at high risk of serious illness or even hospitalization, so it is not intended for the general population, but for a small number of patients who meet medical criteria. Furthermore, as it is administered intravenously, in Greece it will only be administered in Primary Health Care structures or in regular hospital outpatient clinics under strict medical supervision. Finally, being a specially authorized medicine, the availability of Bamlanivimab will be strictly controlled by the competent government agencies.
Trump cocktail
The other antibody preparation, Regeneron REGN-COV2, was cleared by the FDA on November 21. It is a combination of two potent antibodies, casirivimab (casirivimab) and imdevimab (imdevimab), and is indicated for the treatment of recently diagnosed mild to intermediate COVID-19 infection, for high-risk patients over 12 years of age and body weight weighing at least 40 kg.
It’s the antibody cocktail he took Donald trump when he was diagnosed with COVID-19 and made a quick recovery.
REGN-COV2 is recommended for patients at high risk of serious illness or hospitalization (such as people over 65 years of age, with morbid obesity, diabetes, cardiovascular disease or chronic kidney disease, etc.) due to COVID-19 infection. In fact, it is recommended to administer it, also by intravenous infusion, as soon as possible once the COVID-19 infection has been confirmed in the laboratory and definitely within 10 days from the start of symptoms.
Preliminary results from a randomized, double-blind, placebo-controlled phase 2 clinical trial in 799 outpatients showed that when given an intravenous infusion of 1200 mg of casirivimab and 1200 mg of imdevimab, a significant reduction in their viral load. and especially the need to seek medical help and hospitalization. Among the most common side effects are fever, chills, nausea, headache, irritation at the injection site, myalgia, and dizziness. Regeneron continues to evaluate REGN-COV2 as a potential treatment for the prevention or treatment of COVID-19 infection, especially for groups of patients who do not have access to or are adequately protected against approved drugs. vaccines for the disease.
As in the case of bamlanivimab, REGN-COV2 is considered a high-cost drug, since according to press reports in Europe the price is set at around 1,200 euros per vial. However, it is a drug that is administered only once and is aimed at a limited number of high-risk patients, avoiding their deterioration and hospital admission. So you can save money, but also the availability of nursing beds in health systems. The selection of patients expected to benefit from the antibody cocktail will be made according to strict scientific criteria, as defined by the international treatment algorithm for COVID-19 disease. If you finally obtain the special license in our country, its availability will be strictly controlled by the OAS and may be granted only to the structures of the public health system, which is in charge of managing the epidemic in our country.
Greek study
Along with the two innovative drugs mentioned above that may have a catalytic effect in the management of the pandemic, a very important study on monoclonal antibodies begins in our country in mid-December.
According to information from “TOPIC», Three clinical centers in Athena, Thessaloniki Y Alexandroupolis, respectively, have already been selected to participate in an international study conducted under the auspices of the US National Institute of Allergies and Infectious Diseases (NIAID) in Argentina, Australia, Belgium, Brazil, Denmark, France, Georgia, Germany and Mexico. , Poland, Singapore, Spain, Sweden, Uganda, United Kingdom and United States). EOF is reviewing the relevant file and is expected to give the green light for the start of the study in the near future.
It is an international multicenter, adaptive, randomized, double-blind, placebo-controlled clinical trial for the safety and efficacy of new investigational treatments for hospitalized patients with COVID-19. Our country once again seizes the opportunity to make a decisive contribution to scientific research on the treatment of the disease.
A total of 10,000 participants who will be included in the clinical sample (including patients from our country) will receive the research monoclonal antibody LY3819253, in combination with the antiviral remdesivir, or placebo and remedisivir. The objective is to study whether the new combination regimen with monoclonal and antiviral antibodies accelerates recovery, improves respiratory function, avoids the need for mechanical ventilation, and improves mortality rates from disease.
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