The U.S. Department of Health and Human Services has announced plans to distribute Regeneron's monoclonal antibody therapeutics, casirivimab and imdevimab, beginning Tuesday.
Approximately 30,000 doses are ready to be distributed with more to be ready in the coming weeks, according to HHS Secretary Alex Azar.
HHS will allocate these doses to state and territorial health departments which will then determine the healthcare facilities that will receive the therapeutic. Weekly allocations will be based proportionately on confirmed COVID-19 cases and hospitalizations in each state and territory over the previous seven days.
Learn on-demand, earn credit, find products and solutions. Get Started >>
Possible administration 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 treatment will be available at no cost to patients, although healthcare facilities may charge for the administration.
WHAT'S THE IMPACT?
The Regeneron therapeutics received emergency use authorization from the U.S. Food and Drug Administration on November 21, to be administered together for the treatment of mild to moderate COVID-19 non-hospitalized adults and pediatric patients 12 years of age or older weighing at least 88 pounds who are at high risk for severe progression.
The most important sign of efficacy of this treatment in clinical trials was its ability to lower hospitalizations and emergency room visits among patients treated with it, according to Azar.
Under the EUA, casirivimab and imdevimab must be administered together – and in settings where healthcare providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system.
Facilities must have appropriate healthcare staffing, training, equipment and space available to administer the medication in a manner that minimizes infection transmission, HHS said. Therefore, it says that additional preparation time may be required for some treatment locations before they can administer the drug to patients.
THE LARGER TREND
This is now the third drug to be allowed to treat COVID-19 by the FDA.
The first was the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years old and older and weighing at least 88 pounds for COVID-19 treatments requiring hospitalization. This drug should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care, according to the FDA.
The second was Eli Lilly and Company's investigational neutralizing antibody bamlanivimab, which is authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test who are at high risk for progressing to severe COVID-19 and/or hospitalization.
When President Trump was hospitalized with COVID-19, he was treated with remdesivir, the Regeneron therapeutics and several other drugs, including zinc, vitamin D and the generic version of the heartburn treatment Pepcid.
The FDA has still yet to approve a COVID-19 vaccine. However, over the past several weeks Pfizer and Moderna have released efficacy results from their respective trials showing that each candidate is more than 90% effective. Last Friday, Pfizer submitted a request for EUA to the FDA for its candidate.
On Monday, AstraZeneca released data on its vaccine candidate that it has an average efficacy of 70%.
Once a vaccine is authorized by the FDA, officials from Operation Warp Speed say distribution will begin within 24 hours.
ON THE RECORD
"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."
Email the writer: firstname.lastname@example.org