"The emergency authorization of these monoclonal antibodies administered together offers health care providers another tool in combating the pandemic", Patrizia Cavazzoni, MD, acting director of the FDA's Center for Drug Evaluation and Research, said in a statement.
Casirivimab and imdevimab, a monoclonal antibody combo developed by Regeneron Pharmaceuticals, Inc. for treatment of mild to moderate Covid-19, received an emergency use authorization (EUA) from the FDA on November 21.
Examples of people who are high-risk include those who are over the age of 65 or have pre-existing conditions.
It's already reduced COVID-19-related hospitalizations and emergency room visits for patients across the US, including President Trump who was treated with the antibody cocktail after his coronavirus diagnosis. "Importantly, we continue to advance our rigorous clinical trial program evaluating the safety and efficacy of REGEN-COV2 for both the treatment and prevention of COVID-19, and we will share new results as available".
Both Regeneron's drug and another approved treatment, made by Eli Lilly, are synthetic versions of human antibodies that mimic the immune system's ability to fight off harmful pathogens.
Another Chinese COVID vaccine enters late-stage human trials
Global trials are expected to begin in Uzbekistan late this month, followed by trials in Indonesia, Pakistan and Ecuador. The Sinopharm vaccine requires two doses per individual for efficacy.
The initial doses produced by Regeneron will be distributed in the United States: starting this month and covering up to 300,000 patients in total by the end of January. Emergency use authorizations are granted during public health emergencies when a treatment could be effective.
Casirivimab and imdevimab are monoclonal antibodies; their combination injection inhibits the infectivity of SARS-CoV-2, the virus that causes Covid-19.
Antibodies are proteins the body makes to target and help eliminate viruses, but it can take weeks for the best ones to form after an infection occurs. Of these patients, 266 received a single intravenous infusion of 2,400 milligrams casirivimab and imdevimab (1,200 mg of each), 267 received 8,000 mg casirivimab and imdevimab (4,000 mg of each), and 266 received a placebo, within three days of obtaining a positive SARS-CoV-2 viral test.
There's no way to know whether the Regeneron drug helped Trump recover; he received a host of treatments and most COVID-19 patients recover on their own.
The Food and Drug Administration authorized use of the Regeneron Pharmaceuticals Inc. drug to try to prevent hospitalization and worsening disease from developing in patients with mild-to-moderate symptoms.