The US Food and Drug Administration (FDA) released an emergency use authorization to a synthetic antibody for the treatment of mild to moderate COVID-19.
The drug developed by American pharmaceutical company Eli Lilly resulted in lowering the risk of hospitalization and emergency room visits. The monoclonal antibody therapy bamlanivimab is prescribed at a dose of 700 milligrams in adults and children aged 12 years who weigh at least 40 kilograms and older people who are at a high risk of developing the virus into a severe stage.
Bamlanivimab is the first drug to be approved which was particularly developed against the new coronavirus.
“As illustrated by today’s action, the FDA remains committed to expediting the development and availability of potential COVID-19 treatments,” said the agency’s chief Stephen Hahn.
However the safety and effectiveness of this investigational therapy are still being assessed, the approval of bamlanivimab was based on the clinical trial results which reduced COVID-19 related hospitalization in patients at high risk for disease progression within 28 days after treatment when compared to placebo.
In a statement, FDA stated that the significant evidence that the antibody may be effective came from data of phase II trials which showed that among patients at high risk of the virus, hospitalizations and emergency room visits were seen in 3 percent of bamlanivimab-treated patients compared to 10 percent who were on the placebo.
The frequency and type of side effects were most common in both bamlanivimab and placebo, with the majority being mild to moderate in severity. The most seen were diarrhea, dizziness, headache, itchiness and vomiting. The trial is ongoing and aims to enroll more than 800 patients across various dosage groups.
Bamlanivimab is authorized for patients who are hospitalized or require oxygen therapy due to COVID-19, as no benefit has been shown with this treatment in the late stage of the disease when the body’s immune defenses go into overdrive and damage organs.
The FDA stated that using the drug in late-stage could be associated with worse outcomes and a trial exploring bamlanivimab in hospitalized patients was paused last month over a safety incident.
What is Bamlanivimab?
Bamlanivimab is a monoclonal antibody, a relatively new stream of drugs that are best used for treating certain types of cancer and autoimmune disease.
Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses.
Human immune systems produce antibodies, which are infection-fighting proteins and vaccines teach our bodies to be prepared to make the right ones for particular pathogens.
Bamlanivimab was developed based on an effective antibody Eli Lilly found in a recovered patient. The host immune cells that produce the antibodies can be cultured in a lab to produce the desired proteins as a whole. It works by binding to a surface protein of the coronavirus to block the virus’ attachment and entry into human cells.