[ad_1]
The United States Food and Drug Administration (FDA) has issued an emergency marketing authorization for Eli Lilly bamlanivimab for patients with moderate symptoms of Covid-19.
It is an artificial monoclonal antibody that strengthens the defenses of the immune system against coronavirus.
The drug is intended for patients with mild to moderate symptoms, who are at risk of worsening, such as the elderly over 65 and people over 12 with comorbidities due to chronic diseases. It is the first drug approved for patients at a relatively early stage of Covid-19.
Does not benefit those who already need oxygen
The FDA clarified that its license does not apply to 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, on the contrary, it can even worsen their condition. An urgent approval was granted based on the results of a phase 2 clinical trial, which showed that the drug could reduce viral load, symptoms and the likelihood of hospitalization in patients with mild to moderate Covid-19.
About 3% of the trial participants had to go to a hospital emergency department or be admitted, compared with 10% of 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 manufacture one million doses by the end of 2020 and will further expand its production in 2021 to meet international demand, as it is in talks with other countries for drug approvals. 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.
With information from ΑΠΕ-ΜΠΕ
Follow LiFO.gr on Google News and be the first to know all the news
See the latest news from Greece and the world, on LiFO.gr
[ad_2]
