Federal government to start distributing Regeneron experimental coronavirus drug

Federal government to start distributing Regeneron experimental coronavirus drug
Posted at 4:43 PM, Nov 23, 2020

WASHINGTON — The U.S. government on Tuesday will start distributing 30,000 doses of an experimental monoclonal antibody drug to fight COVID-19, the one President Donald Trump received last month.

Over the weekend, the Food and Drug Administration agreed to allowemergency use of the therapeutic, casirivimab and imdevimab, made by Regeneron Pharmaceuticals Inc., for people with mild-to-moderate symptoms who are at high risk of developing serious illness because of their age or other medical conditions.

The treatment was not authorized for use in sicker, hospitalized patients or those who need extra oxygen.

President Donald Trump was given the therapeutic treatmentwhen he contracted coronavirus in October.

The Department of Health and Human Services said the federal government announced funding over the summer to support large-scale manufacturing of casirivimab and imdevimab.

The agency will allocate “these government-owned doses to state and territorial health departments which, in turn, will determine which healthcare facilities receive the infusion drug,” reads a statement from HHS.

“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,” reads the HHS statement.

Antibodies bind to the virus and help the immune system eliminate it. The Regeneron drug is a combo of two antibodies that seemed to do this well in lab tests.

The emergency use authorization allows limited use of a drug while studies continue to test its safety and effectiveness. Early results suggest it may reduce COVID-19-related hospitalization or emergency room visits.

The drugs are given as a one-time treatment through an IV and takes about an hour.

Under federal contracts, the drugs for now will be supplied for free, although patients may have to pay part of the cost of the IV treatment.