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Coronavirus – All News: The US Food and Drug Administration (FDA) has issued an emergency marketing authorization for Eli Lilly bamlanivimab, a man-made monoclonal antibody that strengthens the immune system’s defenses against coronary heart disease.
The drug is intended for patients with mild to moderate symptoms, who are at risk of deterioration, such as the elderly over 65 years of age and people over 12 years old with comorbidities due to chronic diseases. It is the first drug approved for patients at a relatively early stage of Covid-19.
The FDA – in accordance with what the APE-EIA transmits – clarified that its license does not concern the use of the drug in patients who are already hospitalized and need oxygen and that, as previous tests have shown, the drug does not benefit, due to Otherwise it may even make your condition worse. Urgent approval was granted based on the results of a phase 2 clinical trial, which showed that the drug can reduce viral load, symptoms and the likelihood of hospitalization in patients with mild to moderate Covid-19. About 3% of the test participants had to go to an emergency department or be admitted, compared to 10% among those who had taken placebo and were in the control group.
However, more data will be needed for the FDA to give final and full approval to bamlanivimab, the safety and efficacy of which will continue to be evaluated by the US regulatory authority.
The news of the initial approval led to an increase in the company’s participation in the New York Stock Exchange, according to the “Financial Times” and Reuters. Eli Lilly has announced that it will produce one million doses by the end of 2020 and will further expand its production in 2021. to meet international demand, as is the case in talks with other countries for drug approval. The United States government has already purchased 300,000 doses of the drug.
The rival company Regeneron has also requested the urgent authorization of its own drug, two antibodies, which – although in the testing phase – had been used by President Donald Trump.
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