US Govt Purchases Additional 650,000 Doses of COVID-19 Antibody

Eli Lilly & Company recently announced that the US government has purchased 650,000 additional doses of its neutralizing COVID-19 antibody, LY-CoV555, for $812.5 million.

The doses will be delivered through January 3, with 350,000 of the additional doses delivered in December 2020.

Allocation decisions will be based on confirmed COVID-19 cases in each state and territory over the previous seven days, based on data from the HHS collection platform. 

Additionally, global distributions will be based on Eli Lilly & Company’s guiding principles, which will ensure access for patients with high unmet need, no matter where they live.

"Given the significant increase in COVID-19 cases and hospitalizations in the U.S., we are doing everything possible to quickly provide more bamlanivimab doses to Americans," David A. Ricks, Eli Lilly' & Company’s chairman and CEO, said in the announcement.

"We are proud of our work to deploy significant manufacturing capacity and remain committed to enabling widespread and equitable access to bamlanivimab. The U.S. government's effort to allocate bamlanivimab around the country is critical to ensuring it reaches patients who need it the most,” he continued.

In mid-November, FDA issued an emergency use authorization for LY-CoV555 for use in mild to moderate coronavirus in pediatric patients.

Under the authorization, healthcare professionals can administer a single-dose of LY-CoV555 in infected patients 12 years of age or older as long as they weigh at least 88 pounds. Additionally, the treatment can be administered to patients who are at risk for severe COVID-19 or hospitalization, including patients 65 years of age or older with underlying medical conditions. 

But FDA did not authorize the antibody treatment for use in hospitalized patients or patients who require oxygen therapy due to the virus.

FDA based its emergency use authorization on available evidence from the Phase 2 BLAZE-1 clinical trial that evaluated 465 non-hospitalized COVID-19 patients.

Overall, patients treated with LY-CoV555 showed reduced viral load, fewer symptoms, and lower hospitalization rates. Specifically, the antibody 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. 

The first agreement between Eli Lilly & Company and HHS took place at end of October. Together, the Biomedical Advanced Research and Development Authority (BARDA) and the DoD granted $375 million for an initial purchase of 300,000 doses of LY-CoV555 from Eli Lilly. 

The recent additional purchase of the antibody brings the total doses purchased by the US government to 950,000. 

Americans will have no out-of-pocket costs for the medicine, but healthcare facilities can charge a fee for the product’s administration. Eli Lilly & Company stated that it will continue to manufacture LY-CoV555 for use globally and supply is expected to increase significantly in 2021. 

Other top pharmaceutical companies have developed promising COVID-19 antibody treatments, including Regeneron’s antibody cocktail. 

At the beginning of December, HHS announced that it will distribute initial doses of Regeneron’s investigational monoclonal COVID-19 antibody therapy immediately.

Weekly allocations to state and territorial health departments have started based on confirmed COVID-19 cases in each state and territory over the previous seven days.

HHS is promising to ensure fair distribution of the antibody therapy using a data-driven system. The federal department will leverage data from hospitals and state health departments entered into the HHS Protect data collection platform.

“Federal allocation of therapeutics like Regeneron’s, in cooperation with our state and local government partners, will help ensure that they go to the patients who need them the most, just days after the product is authorized,” HHS Secretary Alex Azar said in the announcement.