The FDA said the monoclonal antibodies, casirivimab and imdevimab, should be given together for the treatment of mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing and who are in danger of advancing to severe COVID-19.
AstraZeneca EVP: Hoping for coronavirus vaccine dialogue with FDA ‘sooner than later’ ||Mornings with Maria 6-9 AM et M-F on Fox Business-- Mariabartiromotv Mariabartiromotv Monday, November 23, 2020
This involves those who are 65 years of age or older or who have certain permanent medical conditions.
The medication is part of a class of drugs known as monoclonal antibodies, which produce copies of antibodies generated by the human body to fight infections.
Regeneron's REGEN-COV2 "antibody cocktail" - including an antibody made by the company and a second isolated from humans who healed from COVID-19 - is designed so that the two antibodies search and bind to the coronavirus' spike protein to blocking it from entering healthy human cells.
Regeneron said on Saturday the clinical proof from an outpatient trial implies that monoclonal antibodies such as REGEN-COV2 have the greatest contribution when given early after testing and in patients who have not yet mounted their own immune response or who have a high viral capacity.
Why wear a #MASK when there's #REGENERON ❓-- Yolanda Aguilar YolandaAguilar57 Monday, November 23, 2020
The company said it predicts to have dozens of REGEN-COV2 treatments ready for about 80,000 patients by the end of this month, about 200,000 patients by the first week of January, and about 300,000 patients in total by the end of January.
The FDA said the antibodies are not authorized for patients who are hospitalized due to COVID-19 or need oxygen therapy due to COVID-19.
Trump spent three days at Walter Reed after he caught the virus in early October, where he got a series of experimental treatments, including an antibody therapy from Regeneron.
Monoclonal antibodies treatments are also being developed by Eli Lilly and other companies.
The drugs imitate antibodies that the immune system naturally creates to fight off viruses and other pathogens.
Extremely frail relative in late 80's locked down in severe Parkinson's unit, social distancing plus masks , got COVID last week. ICU, back to longterm care, back to ICU with double pneumonia. Received #REGENERON Better Next day, up walking around. Completely BETTER.-- Iris Crane IrisCrane15 Monday, November 23, 2020
Trump later recognized the experimental drug therapy with assisting his recovery.
Trump returned to the White House on Monday October 5 after spending three days hospitalized at Walter Reed Military Medical Center in Maryland for coronavirus.
The monoclonal antibody cocktail is deemed as experimental because clinical trials are ongoing and it hasn’t been approved for the market by the FDA.
Trump was able to get it through the FDA’s "compassionate use" provision, where unapproved drugs are given to seriously ill patients who have no other treatment options.
While Regeneron has shared assuring results of the treatment, which cut the viral load of COVID-19 patients who were not hospitalized, there is no proof the drug lowered the risk of death or "cured" patients.