In this May 2020 photo provided by Eli Lilly, researchers prepare mammalian cells to produce possible COVID-19 antibodies for testing in a laboratory in Indianapolis.
David Morrison | Eli Lilly via AP
States and local health-care systems should expect to face some early challenges administering Eli Lilly‘s coronavirus antibody drug, senior administration officials warned Tuesday, after the FDA authorized the drug to treat patients with Covid-19.
Eli Lilly’s drug, similar to the one given to President Donald Trump after he contracted the virus last month, is administered to Covid-19 patients via an IV infusion that takes more than an hour and requires another hour of observation afterward, officials said. That may be difficult in certain health-care settings, and Eli Lilly and the U.S. government are developing “playbooks” to help states navigate the process, said Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research.
“We anticipate that initially there’ll be challenges for the health-care system in administering IV infusions to infected patients,” Woodcock said on a conference call with reporters. “There are probably going to be multiple different solutions depending on the setting, [like] community health centers, home IV, health infusion companies, nursing homes.”
The Food and Drug Administration on Monday authorized the treatment, called bamlanivimab, for people newly infected with Covid-19 and who are seen as at risk of developing a severe form of the disease. Officials said the treatment shouldn’t be used to treat patients who are hospitalized as there is currently no data to show the drug is helpful at that stage of the disease.
The drug will “likely work best early in the disease and the goal during this [emergency use authorization] should be to treat high-risk individuals as soon as possible after they have symptoms and are diagnosed,” Woodcock said. “The data we have suggests that early treatment may help people avoid disease progression and avoid hospitalization.”
“We’re all going to need to get the word out that people at high risk have a therapeutic option now .. Because until this point, people have been told to stay at home unless they get very sick,” she added.
Health and Human Services Secretary Alex Azar said the U.S. government, through Operation Warp Speed, will begin distribution of the drug this week. Allocation of the drug will be based on states’ and territories’ share of the country’s total number of confirmed Covid-19 patients and the total number of confirmed hospitalized patients in a given week, he said. The drug will be distributed in two phases, with hospitals and hospital-affiliated locations getting it first, followed by outpatient centers.
Health-care facilities must have the appropriate staffing, training and equipment to accommodate an IV infusion, according to Dr. John Redd, chief medical officer for the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services.
“We have a contract to purchase 300,000 doses of this product through December with the option to purchase another 650,000 doses through next June as well,” Azar said. “There are over 80,000 doses available for allocation and distribution this week, and we’ll be working with state, local and territorial health departments so that patients can receive the infusion in hospitals, outpatient clinics or alternate care settings.”
Eli Lilly’s drug is part of a class of treatments known as monoclonal antibodies, which are made to act as immune cells that scientists hope can prevent the virus from infecting cells. A recent study in the New England Journal of Medicine found 1.6% of trial participants who received Eli Lilly’s antibody treatment ended up hospitalized or had a coronavirus-related visit to the emergency room, compared with 6.3% of people who received the placebo.
Eli Lilly Chairman and CEO Dave Ricks told CNBC earlier in the day that the company’s antibody drug will still be an important treatment for Covid-19, even if a widely available vaccine is brought to market.
Even in well-controlled [other] respiratory illness … we still have vaccination and antibody therapy because some patients escape the vaccine and still get the condition, and they need to be managed with a therapy,” he added. “This will be useful in the long term, hopefully at much lower volumes” in fighting Covid-19 as well.
–CNBC’s Kevin Stankiewicz contributed to this report.