The US Food and Drug Administration (FDA) has issued a second emergency use authorization of monoclonal antibodies for the treatment of COVID-19.
What We Know:
- This experimental drug made by Regeneron Pharmaceuticals Inc. is one of the treatments Trump received during his sickness. It is a combination of two monoclonal antibodies-casirivimab and imdevimab- that are administered together through an IV. The monoclonal antibodies are made in a laboratory, created to mimic the immune system’s ability to fight off viruses. Regeneron’s antibody treatment is similar to the first antibody-drug, produced by Eli Lilly, that was approved for use earlier this month.
- This treatment is solely for mild to moderate cases in adult and pediatric patients over 12 who are at risk of hospitalization. Like the treatment from Eli Lilly, Regeneron’s treatment has not shown to be effective for patients already hospitalized due to COVID-19. The FDA New Release stated monoclonal antibodies like casirivimab and imdevimab could actually worsen “clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.”
- An approval from the FDA and an emergency use authorization are not the same. The issuance of a EUA means the antibodies’ safety and effectiveness are still being tested, and this is a temporary approval. The FDA’s authorization was determined by data “based on a randomized, double-blind, placebo-controlled clinical trial” with about 800 coronavirus adult patients with mild to moderate symptoms. By the end of this month, Regeneron says they expect to have enough doses for 80,000 patients, with 300,000 in total by the end of January. While the treatment itself will be free, patients will possibly have to pay the cost of administering the IV.
- Following his positive diagnosis of coronavirus, Trump was given several drugs, including Regeneron’s drug, REGEN-COV2. Considering this, there is no way to be certain that this specific antibody is owed credit for his recovery yet, he still gave it much praise. “I want to get you the same care that I got, I got incredible treatment… and this one medicine, in particular, was unbelievable. You are going to get the same medicine, and you are going to get it free, and soon,” he said in a video posted on Twitter.
- US Housing Secretary Ben Carson was extremely ill from the virus and said Trump gave him clearance for Regeneron’s antibody therapy. Carson says he is convinced it saved his life. In the same way as Trump, the true cause of Carson’s recovery cannot be determined. Regardless The White House has spent nearly half a billion dollars funding the large-scale manufacture of Regeneron’s antibody drugs to be delivered to US hospitals.
FDA demands patients, caregivers, and health care providers, be provided with facts sheets that contain important information about using Regeneron’s combination of drugs to treat COVID-19. The news release states that “these fact sheets include dosing instructions, potential side effects and drug interactions.”
