The U.S. Department of Health and Human Services today announced plans to allocate initial doses of Regeneron’s investigational monoclonal antibody therapeutic, casirivimab and imdevimab, which received emergency use authorization from the U.S. Food and Drug Administration on November 21, 2020, for treatment of non-hospitalized patients with mild or moderate confirmed cases of COVID-19 at high risk of hospitalization.
In July, the federal government announced federal funding to support large-scale manufacturing of casirivimab and imdevimab with approximately 300,000 doses of the medicine expected to result from the project. HHS will allocate these government-owned doses to state and territorial health departments which, in turn, will determine which healthcare facilities receive the infusion drug.
“Authorization and distribution of this new Regeneron antibody treatment is another 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,” said HHS Secretary Alex Azar. “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.”
“We are committed to the equitable and efficient distribution of resources like casirivimab and imdevimab to help prevent hospitalization from COVID-19 as much as possible,” said HHS Assistant Secretary for Preparedness and Response Robert Kadlec, M.D. “To that end, we are coordinating with Regeneron, 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.”
A data-driven system will ensure continued fair and equitable distribution of these new products. Beginning immediately, weekly allocations to state and territorial health departments will be proportionally based on confirmed COVID-19 cases in each state and territory over the previous seven days, based on data hospitals and state health departments enter into the HHS Protect data collection platform.
“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 within hours,” Dr. Kadlec added.
The intravenous administration of therapeutics to non-hospitalized patients with confirmed mild to moderate COVID-19 presents unique challenges. To accommodate IV infusions, outpatient facilities must have appropriate healthcare staffing, training and equipment. As such, additional preparation time may be required for some treatment facilities before they can administer the drug to patients.
The infusion process takes approximately one hour and may followed by an observation period. Under the EUA, casirivimab and imdevimab must be administered together and in settings where health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary. Facilities also must have space available to administer the medication in a manner that minimizes infection transmission.
Possible locations include hospital outpatient facilities, hospital emergency departments, and alternate care sites set up by hospitals and health departments under the ‘hospital without walls’, flexibility provided by the Centers for Medicare and Medicaid Services to support a surge of hospitalized patients. The government-owned doses will be available at no cost to patients, although healthcare facilities could charge for administering the medicine – as is customary with such government-purchased products. CMS created a billing code for reimbursement of these costs for Medicare patients.
Regeneron developed casirivimab and imdevimab with preclinical and clinical development support through a long-standing flexible agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response. Regeneron used the same proprietary technology platforms and cocktail approach to develop a novel triple antibody treatment for Ebola that is now under regulatory review by the FDA.
Currently, casirivimab and imdevimab is being evaluated in an ongoing clinical trial as part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership led by the National Institutes of Health with funding and other support from the BARDA. ACTIV is part of a coordinated research strategy to prioritize and speed development of the most promising treatments and vaccines.
The medicine is a combination of two virus-neutralizing monoclonal antibodies. Monoclonal antibodies, which mimic the human immune system, are produced outside of the body by a single clone of cells or a cell line with identical antibody molecules and then delivered to patients by injection or infusion. The antibodies bind to certain proteins of a virus, reducing the ability of the virus to infect human cells.
Allocation of casirivimab and imdevimab will be allocated to specific states, territories, and jurisdictions this week and in subsequent weeks. The allocation dashboard will be updated each distribution week.
The drug is the third COVID-19 therapeutic for which HHS has provided allocation oversight. The first, Veklury (remdesivir), gained FDA approval and is now widely available, and earlier this month HHS began allocation oversight of the second, bamlanivimab from Eli Lilly and Company. Working with the Department of Defense, HHS is partnering with multiple other companies to develop, manufacture and make available therapeutics to treat COVID-19.
About HHS, ASPR, and BARDA:
HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, 56 BARDA-supported products have achieved FDA approval, licensure or clearance. For more on BARDA’s portfolio for COVID-19 diagnostics, vaccines and treatments and about partnering with BARDA, visit medicalcountermeasures.gov. To learn more about federal support for the all-of-America COVID-19 response, visit coronavirus.gov.