The antibody drug developed by GSK and Vir Biotechnology for use in the early treatment of new types of patients with coronavirus (Kovid-19) has been approved for emergency use by the US Food and Drug Administration (FDA) United.
According to the company’s statement, the positive results from the drug’s Phase 3 study played a role in the FDA’s approval for emergency use of the antibody.
An emergency use license has been granted by the FDA for the monoclonal antibody drug developed by GSK and Vir Biotechnology for use in the early treatment of Kovid-19 patients who are at risk of developing serious complications.
The interim results of this study showed an 85% reduction in the risk of hospitalization or death in high-risk COVID-19 positive adult patients compared to placebo. Additionally, laboratory data revealed that the drug was effective against all known variants, including the Indian variant.
In accordance with the FDA’s emergency use approval, the drug is expected to be available to eligible patients diagnosed with COVID-19 in the United States in the coming weeks.
The processes with the European Medicines Agency (EMA) and other global regulatory authorities for the emergency use approval of the medicine are continuing.
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The EMA Human Medicinal Products Board evaluated the analysis of efficacy and safety data obtained from the efficacy study of Kovid-19 monoclonal antibodies in adults at high risk of hospitalization, and a gave a positive opinion about the drug in the last few days.
WHAT IS THE MONOCLONAL ANTIBODY AND WHAT DOES IT DO IN THE BODY?
Foreign molecules that cause the immune system to produce antibodies when they enter the body are called antigens. “Monoclonal antibody” is the name given to antibodies produced specifically for an antigenic structure. When a microorganism is encountered under normal conditions, antibodies are produced according to many antigenic structures of that organism. These antibodies, which are used as immune plasma, were obtained and applied by collecting plasma from people with this disease for Kovid-19.
The administration of multiple and varied antibodies has been used in therapy, although it carries many unknown and undesirable risks. This treatment can still be used in selected patients and at the start of the period. Monoclonal antibodies, on the other hand, are antibodies directed against the antigens of the region (S protein) of the virus that bind to cells, obtained only by cells constructed under laboratory conditions.
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Monoclonal antibodies attach themselves to the targeted region and prevent the activity of that region. These antibodies, which bind to the S protein of Kovid-19, prevent attachment to target cells, entry into the cell and thus prevent infection or progression.
Monoclonal antibody therapy is the opposite of plasma cell therapy for patients who have recovered from COVID, which has been used so far in some countries.
Plasma, a yellowish liquid that is the liquid part of the blood, is obtained in this method by multiplying various antibodies in the plasma taken from patients recovered from the coronavirus.
So there are polyclonal antibodies, i.e. different antibody clones, and each different antibody clone attaches to different parts of the virus.
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Monoclonal antibodies have been used since the 1980s to fight against various diseases, including certain types of cancer.
A study conducted in nursing homes in the United States found that monoclonal antibodies produced in large quantities by multiplying under laboratory conditions may be effective in preventing people from contracting the coronavirus as well as in treatment.