World news – African Union – Culture: The Food and Drug Administration approves emergency clearance for a nighttime antibody treatment to COVID-19

– Yus The Food and Drug Administration (FDA) said Monday it has issued a clearance for emergency use to treat Eli Lilly and Co with monoclonal antibodies to treat mild to moderate infections of the Coronavirus in adults and children

Single antibody therapy, called mlanifemab, should be offered in a hospital or other health care setting. It is the first monoclonal antibody approved for use in treating the Coronavirus The idea is to trigger an immune response against the infection

“Monoclonal antibodies are proteins made in the laboratory that mimic the ability of the immune system to fight harmful antigens such as viruses.” The Food and Drug Administration said in a statement that Bamlanivimab is a monoclonal antibody that specifically targets the SARS-CoV-2 protein, which is designed to prevent The virus attaches to and enters human cells

“The Food and Drug Administration (FDA) emergency clearance of Pamnifemap provides healthcare professionals on the front lines of this pandemic another potential tool in treating patients with COVID-19,” Dr. Patricia Cavazzoni, Acting Director of the FDA’s Center for Drug Evaluation and Research, said in the statement, « We will continue to evaluate new data on the safety and efficacy of manivimab as they become available. »

The FDA statement based on a study published in the New England Journal of Medicine in October found that the treatment appeared to reduce the risk of hospitalization and relieve some symptoms in a small number of patients with mild to moderate cases of Covid-19

The Phase 2 trial involved 452 patients, some who received the treatment and others a placebo that did nothing. 1 Only 6% of the patients who received the treatment had symptoms advanced enough to be admitted to hospital or seek emergency room care. For patients who received placebo, the hospitalization rate was 63%

Lilly announced that it had reached an agreement worth $ 375 million with the government to obtain 300,000 vials of antibody therapy, pending emergency permission, to be delivered within two months. Lilly applied for an emergency permit in October and the company said it intended to obtain Over 100,000 doses are ready to be shipped within a few days and will manufacture one million doses by the end of 2020 Treatment will be provided to patients at no cost

The company said in a statement: « Lilly will begin shipping bamlanivimab immediately to AmerisourceBergen, the national distributor, who will position it as directed by the US government’s allocation schedule. »

“Based on the FDA’s review of all available scientific evidence, the agency has determined that it is reasonable to believe that pamlinivimab may be effective in treating out-of-hospital patients with mild or moderate COVID-19 virus,” the FDA said

When used to treat COVID-19 in an authorized population, the known and potential benefits outweigh the known and potential risks of the drug. There are no adequate, approved, alternative treatments available to bamanivimab for the authorized population. « 

The FDA said treatment should be given as soon as possible after a positive COVID-19 test result, within 10 days of the onset of symptoms. It can only be administered in a health care setting where doctors also have access to medications in case a patient has a bad reaction to an infusion.Treatment providers who use the treatment should also inform the FDA if there are any serious adverse events, he says. Emergency permit

The treatment is not authorized for inpatients or who require oxygen therapy, as it does not appear to help them

For months, hope was gathering around monoclonal antibody therapies as a possible treatment for COVID-19

Once the epidemic hit the United States in January, night scientists went to work to identify the antibody, which is one of the proteins that the body naturally makes to fight infection, and that would better protect against the new Corona virus

Scientists examined thousands of antibodies generated by a patient who had recovered from COVID-19.They found, selected, and then copied those they thought would be best to neutralize the virus, and chose one for an advanced treatment that entered human clinical trials in June.

Regeneron has also applied for emergency use permission for his antibody treatment. This is the one that was given to the President of the United States, Donald Trump, last month when he contracted the Coronavirus

“Licensing of Eli Lilly’s new antibody therapy is an important step forward in treating patients and is leading us to implement safe and effective vaccines, with all these efforts made possible through Operation Warp Speed,” he said. In contact with the Minister of Health and Human Services, Alex Azar

« Operation Warp Speed ​​helps ensure treatments like Lilly reach patients without wasting a single day »

Lilly is also testing pamlanifimab with another monoclonal strain that she developed. A peer-reviewed study in August showed that Regeneron’s « cocktail » approach using two antibodies combined with its treatment worked in vitro even when the coronavirus mutated

Eli Lilly and Company, Food and Drug Administration, Emergency Use Permission, Antibody, Coronavirus, Monoclonal Antibody Therapy, Healthcare