US officials warn of challenges in administering Eli Lilly’s antibody drug

States and local health systems should expect to face some early challenges when administering Eli Lilly’s anti-coronavirus drug, senior administration officials warned Tuesday, after the FDA announced authorized the drug to treat patients with Covid-19.

Eli Lilly’s drug, similar to the one given to President Donald Trump after contracting the virus last month, is given to Covid-19 patients via an IV drip that takes over an hour and requires another hour of observation afterwards, officials said. This can be difficult in some healthcare settings, and Eli Lilly and the US government are developing “playbooks” to help states navigate the process, said Dr Janet Woodcock, director of the Center for Drug. FDA Evaluation and Research.

“We anticipate that initially there will be challenges for the health care system in administering IV infusions to infected patients,” Woodcock said on a conference call with reporters. “There will probably be several different solutions depending on the setting, [like] community health centers, IV at home, medical infusion companies, nursing homes. “

The Food and Drug Administration on Monday cleared the treatment, called bamlanivimab, for people newly infected with Covid-19 who are considered at risk of developing a severe form of the disease. Officials said the treatment should not be used to treat hospital patients because there is currently no data to show that the drug is helpful at this stage of the disease.

The drug “will probably work best at the onset of 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, “said Woodcock.” The data we do have suggests that early treatment can help people avoid progression to disease. illness and avoid hospitalization.

“We’re all going to need to make it known that high risk people now have a treatment option. Because so far people have been told to stay home unless they get very sick, ”she added.

Health and Human Services Secretary Alex Azar said the US government, through Operation Warp Speed, will begin distributing the drug this week. The allocation of the drug will be based on the states and territories share of the total number of confirmed Covid-19 patients in the country 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 establishments affiliated with the hospital receiving it first, followed by outpatient centers.

Healthcare facilities should have the proper staff, training and equipment to accommodate an intravenous drip, says Dr John Redd, chief medical officer in the office of the assistant secretary for breast preparedness and response. from the US Department of Health and Human Services.

“We have a contract to purchase 300,000 doses of this product until December with the possibility of purchasing an additional 650,000 doses until next June,” Azar said. “There are over 80,000 doses available for allocation and distribution this week, and we will work with state, local and territorial health departments to ensure patients can receive the infusion in hospitals, outpatient clinics or other care settings. “

Eli Lilly’s drug is one of a class of treatments known as monoclonal antibodies, which are designed to act like immune cells that scientists hope can prevent the virus from infecting cells. A recent study published in the New England Journal of Medicine found that 1.6% of trial participants who received Eli Lilly antibody treatment ended up hospitalized or had a visit to the emergency room related to the coronavirus, against 6.3% of people who received placebo.

Eli Lilly chief executive officer Dave Ricks told CNBC earlier today that the company’s antibody drug will remain an important treatment for Covid-19, even as a widely available vaccine is brought to market.

Even in a well-controlled environment [other] respiratory disease … we still have the vaccination and antibody therapy because some patients escape the vaccine and continue to get the disease, and they have to be managed with therapy, “he added.” This will help in the long term, hopefully at much lower volumes “in the fight against Covid-19 as well.

– CNBC’s Kevin Stankiewicz contributed to this report.