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The US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) on Monday for the investigational monoclonal antibody therapy bamlanivimab (Eli Lilly) to treat adults and children with mild to moderate COVID-19.
The monoclonal antibody therapy has emergency authorization for treating patients who have tested positive for SARS-CoV-2 infection and who are considered to be at high risk for progression to severe COVID-19 or hospitalization. To be eligible for treatment with bamlanivimab, patients must be at least 12 years of age and weigh at least 40 kg (approximately 88 lb). The agency notes that this includes patients aged 65 years and older or people with certain chronic conditions.
Bamlanivimab is not authorized for use in patients who are hospitalized or who require oxygen therapy because of COVID-19. The FDA's action comes less than 2 weeks after Eli Lilly halted the ACTIV-3 study of the therapy for severe, hospitalized COVID-19 patients after evidence showed that adding the antibody therapy to standard care did not improve outcomes over standard care alone for patients with advanced COVID-19.
The government contract with Eli Lilly involves the purchase of 300,000 doses through December, with the option to procure another 650,000 doses through June 2021.
Because of Operation Warp Speed, "we have supplies to distribute now. Product distribution will begin this week," US Health and Human Services (HHS) Secretary Alex Azar said at a news conference today.
"We talked about building the bridge to safe and effective vaccines" for COVID-19, Azar added. "With this therapeutic, the bridge is taking shape."
Bamlanivimab 700 mg will be administered as a 1-hour infusion followed by a 1-hour observation period for detecting any infusion-related side effects. The authorized dose is 700 mg, which was on the lower end of the dose range evaluated in studies.
During the press conference, a reporter asked whether the lower dose was chosen in order that more doses of the antibody could be made available. "The lower dose is a rational choice in this situation because we don't want to give more of a drug than you need," said Janet Woodcock, MD, the therapeutics lead for Operation Warp Speed. "I think we could probably go lower."
Bamlanivimab works by attaching to the virus and blocking its entry into the cells and possibly by helping the patients' immune system clear the virus, said Woodcock, who is also director of the FDA's Center for Drug Evaluation and Research.
"The goal is to treat high-risk people as soon as possible after they show symptoms and are diagnosed," she added.
Infusions an Initial Challenge?
There could be some logistic challenges at first because the antibody is administered via infusion. "We expect there will initially be a challenge in administering...these infusions and setting up infusion centers," Woodcock said.
Outpatient intravenous infusions are normally performed at infusion centers for patients with cancer and immune disorders, she noted. "You really don't want them mixing with people who have COVID-19 disease, so we will need to set up separate sites."
Bamlanivimab will be provided free of cost to patients, Azar said. Patients should be aware that coinsurance may be required for the infusion.
"Fair and Equitable" Distribution Planned
During phase 1 of distribution, the agent will first be allocated to hospitals and hospital-affiliated locations only, John Redd, MD, MPH, chief medical officer, Office of the Assistant Secretary for Preparedness and Response at HHS, said at the press conference.
During phase 2, "there will be expanded distribution to outpatient sites," he said. In an effort to keep the process transparent, a new website features the latest updates on the distribution of bamlanivimab.
Allocation will be based on two factors: the number of new cases reported in a state or territory in the prior 7 days, and rates of COVID-19 hospitalization during the same period.
Asked why the government would determine distribution of the antibody on the basis of the number of hospitalized patients when the indication includes prevention of admission, Woodcock replied that hospitalization is a surrogate measure that can reflect risk factors in a particular state population, such as obesity, diabetes, or the proportion of older people.
Furthermore, the confirmed cases are a "leading indicator," she said, that can help identify a steep rise in COVID-19 cases that could indicate more hospitalizations are likely soon. "We don't want to miss that."
Data Underlying the EUA Decision
A decrease in hospitalizations or emergency department visits within 28 days of treatment in preclinical studies was "the most important evidence that bamlanivimab may be effective," the agency noted in the press release announcing the EUA. Among patients at high risk for progression, 3% required such interventions, compared with 10% of placebo-treated patients.
Potential side effects of bamlanivimab include anaphylaxis, infusion-related reactions, nausea, diarrhea, dizziness, headache, itching, and vomiting.
"As illustrated by today's action, the FDA remains committed to expediting the development and availability of potential COVID-19 treatments and providing sick patients timely access to new therapies where appropriate," FDA Commissioner Stephen M. Hahn, MD, said in the news release.
Healthcare providers can download a detailed FDA fact sheet on the EUA for bamlanivimab, which includes dosing instructions.
Damian McNamara is a staff journalist based in Miami. He covers a wide range of medical specialties, including infectious diseases, gastroenterology and neurology. Follow Damian on Twitter: @MedReporter.
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Cite this: FDA Grants Emergency Use Authorization to Lilly's Antibody COVID-19 Therapy - Medscape - Nov 10, 2020.