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HHS Buys 300K Doses of Eli Lilly’s COVID-19 Antibody Treatment
After receiving FDA emergency use authorization, HHS will now allocate nearly 300,000 doses of Eli Lilly’s COVID-19 antibody treatment to be distributed in the US.
HHS announced that will allocate initial doses of Eli Lilly & Company’s COVID-19 antibody treatment after it recently received emergency use authorization from the FDA.
At the end of October, HHS and the Department of Defense made an agreement with Eli Lilly to purchase 300,000 doses of LY-CoV555 and distribute the doses to state and territorial health departments.
The agreement, part of the Trump Administration’s goal of delivering life-saving vaccines and therapeutics through Operation Warp Speed, will also allow the federal government to obtain nearly 650,000 additional doses if needed through June of next year for up to $812.5 million.
Under the allocation agreement, LY-CoV555 may only be administered in settings in which healthcare providers have immediate access to medications to treat any adverse reactions and in a facility that minimizes infection spreading, HHS said.
“Authorization and distribution 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,” HHS Secretary Alex Azar, said in the announcement.
“Federal allocation of therapeutics like Lilly’s, in cooperation with our state and local government partners, will help ensure that they go to the patients who need them most just days after the product is authorized.”
Yesterday, FDA issued an emergency use authorization to LY-CoV555 for use in mild to moderate COVID-19 in adults and pediatric patients.
Under the authorization, healthcare providers can administer a single dose of the antibody in infected patients 12 years of age or older as long as they weigh at least 88 pounds.
The authorization also stated that the treatment may be administered to patients who are at risk for severe COVID-19 or hospitalization. This includes patients 65 years of age or older with underlying medical conditions.
FDA based its emergency use authorization on available evidence from the Phase 2 BLAZE-1 trial that evaluated 465 non-hospitalized COVID-19 patients.
Specifically, LY-CoV555 reduced coronavirus-related hospitalizations or emergency room visits in patients within 28 days after treatment compared to a placebo group.
For patients at high risk for disease progression, hospitalizations and emergency room visits occurred in 3 percent of patients treated with LY-CoV555, compared to 10 percent of patients treated with placebo.
Under the agreement with Eli Lilly, HHS stated that weekly allocations to state and territorial health departments will be proportionately based on confirmed COVID-19 cases in each state and territory over the last seven days.
HHS will acquire this data from hospitals and state health departments.
“We are coordinating with Lilly, its distributor, and state and territorial health departments to get therapeutics into the hands of healthcare providers quickly, with a focus on areas of the country currently hardest hit by the pandemic,” said HHS Assistant Secretary for Preparedness and Response Robert Kadlec, MD.
“We have worked with state and territory partners to refine the process based on experience with previous therapeutics and diagnostics and now expect that after pulling this weekly data, shipments can be on their way the same day,” Kadlec added.
Currently, LY-CoV555 is being evaluated in multiple clinical trials, including a trial part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), a public-private partnership led by the National Institutes of Health (NIH). The trial has also received funding and other support from the Biomedical Advanced Research and Development Authority (BARDA).
Eli Lilly anticipates manufacturing up to 1 million doses of LY-CoV555 by the end of the year, with 100,000 doses ready to ship for use globally.
HHS noted that LY-CoV555 is the second COVID-19 therapeutic requiring HHS allocation oversight. The first – Veklury (remdesivir) – gained FDA approval back in May and is now widely available.
