The nation has been fighting the back-and-forth surge of the COVID pandemic since late March. During those months, millions of people have been jobless and countless businesses have shuttered their doors in an attempt to flatten the curve.
Hope might be on the horizon.
The US Food and Drug Administration announced there was an emergency use authorization for Eli Lilly and Co’s single antibody treatment. Bamlanivimab, a monoclonal antibody therapy used to treat mild to moderate coronavirus infections, must be infused in a health care setting. The new treatment, is hopeful to kick-start the body’s immune response against infection, is the first monoclonal antibody to be authorized in treating the coronavirus.
"Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off harmful antigens such as viruses. Bamlanivimab is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2, designed to block the virus' attachment and entry into human cells," the FDA said in a statement on November 9, 2020.
Dr. Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research said the new drug could be an important tool.
"The FDA's emergency authorization of bamlanivimab provides health care professionals on the frontline of this pandemic with another potential tool in treating Covid-19 patients," Cavazzoni said in the statement. "We will continue to evaluate new data on the safety and efficacy of bamlanivimab as they become available."
Emergency authorization does not mean full approval
The FDA noted there is a difference between an emergency use authorization and an approval.
"Based on the FDA's review of the totality of the scientific evidence available, the agency determined that it is reasonable to believe that bamlanivimab may be effective in treating non-hospitalized patients with mild or moderate Covid-19," the FDA said.
"And, when used to treat Covid-19 for the authorized population, the known and potential benefits outweigh the known and potential risks for the drug. There are no adequate, approved and available alternative treatments to bamlanivimab for the authorized population."
The treatment seems to only be effective during the early stages of the sickness. It should be administered immediately after a positive Covid-19 test result, within ten days of the onset of symptoms. Due to the infancy of the drug trials, it is important to only administer the treatment in a health care setting, so the doctors cane have access to medication in case the patient has a bad reaction to the infusion.
The treatment is not recommended for patients who are hospitalized or on oxygen because it does not seem to help them.
Health and Human Services Secretary Alex Azar said the treatment is a noteworthy step toward hope; something the country has been needing for months.
"Authorization of this new Eli Lilly antibody treatment is a significant step forward in treating patients and bridging us to the rollout of safe and effective vaccines, with all of these efforts made possible by Operation Warp Speed," Azar said in a statement.
"Operation Warp Speed is helping to ensure that therapeutics like Lilly's can reach patients without a day wasted."