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The single antibody treatment, called bamlanivimab, must be infused in a hospital or other health care setting.. It is the first monoclonal antibody to be authorized for the treatment of coronavirus. The idea is to initiate an immune response against the infection.
“The emergency clearance of bamlanivimab by the FDA provides healthcare professionals on the front lines of this pandemic with another potential tool to treat patients with Covid-19,” said Dr. Patrizia Cavazzoni, Acting Director of the FDA Center for Drug Evaluation and Research. . “We will continue to assess new data on the safety and effectiveness of bamlanivimab as it becomes available.”
The Phase 2 trial involved 452 patients, some of whom received the treatment and others received a placebo, which does not matter. Only 1.6% of the patients who received the treatment had symptoms advanced enough to require hospitalization or emergency treatment. For patients who received placebo, the hospitalization rate was 6.3%.
Lilly announced that she had reached a $ 375 million deal with the government for 300,000 vials of antibody treatment, pending EUA, to be delivered within the next two months. Lilly applied for the EUA in October. The company said it plans to have 100,000 doses ready to ship within days and will manufacture a million doses by the end of 2020. Treatment will be provided to patients at no cost.
Emergency clearance is faster than full approval
“Issuing an EUA is different from FDA approval,” the FDA noted.
“Based on the FDA’s review of all of the available scientific evidence, the agency has determined that it is reasonable to believe that bamlanivimab may be effective in the treatment of outpatients with mild Covid-19 or moderate, ”the FDA said.
“And, when used to treat Covid-19 for the licensed population, the known and potential benefits outweigh the known and potential risks to the drug. There are no adequate, approved and available alternative treatments to bamlanivimab for the licensed population.
Treatment should be given as soon as possible after a positive Covid-19 test result, within 10 days of onset of symptoms, the FDA said. It can only be given in a health care setting where doctors also have access to medication in case the patient has a bad reaction to the infusion. Providers who use the treatment must also notify the FDA of any serious adverse events, according to the EUA.
Treatment is not allowed for patients who are hospitalized or require oxygen therapy, as it does not appear to help them.
For months, hope has been built around monoclonal antibody therapies as a potential treatment for Covid-19.
As soon as the pandemic hit the United States in January, scientists at Lilly got to work identifying an antibody, one of the proteins the body makes to naturally fight infection, which would best protect against the new coronavirus.
Scientists sifted through thousands of antibodies generated by a patient who had recovered from Covid-19. They found, selected and then copied the ones they thought would best neutralize the virus and picked one for a cutting-edge treatment that went through human clinical trials in June.
Regeneron has also applied for emergency use authorization for its antibody treatment. It’s the one given to President Trump last month when he caught coronavirus.
“The authorization of this new Eli Lilly antibody treatment is an important step forward in the treatment of patients and brings us closer to the deployment of safe and effective vaccines, all of which are made possible by Operation Warp Speed,” said Alex Azar, Secretary of Health and Social Services. in a report.
“Operation Warp Speed is helping to ensure that therapies like Lilly’s can reach patients without wasting a day.”
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