Monoclonal Antibodies, What is the First US-Approved Targeted Therapy and How It Works

Media coverage of the race to develop Covid vaccine candidates has somewhat “obscured” the work of researchers working on the other side of the battle against the new coronavirus: not the prophylactic but the therapeutic. We have been talking about at least since May monoclonal antibodies and the possibility that they become game changer of the fight against the pandemic, a complementary tool to the vaccine. The experiments not only began last August, but also ended with the approval of the Food and Drug Administration. And the news from the United States is comforting.

L’immunologist Antonella Viola On the Facebook page where he answers a question every day, he writes: “Monoclonal antibodies from companies Lilly me Regeneron The FDA has long approved them for emergency use. Why not in Europe? The US authorization refers to patients at least 12 years old, not hospitalized (therefore in the initial stages of infection) but at high risk of developing severe Covid-19 (obese with BMI> 35; older 65; with chronic diseases such as diabetes, kidney, cardiovascular, respiratory diseases, etc.). It seems increasingly evident that times make a difference and that to prevent the development of the severe form of the disease more effective than intervening late. This delay in Europe is surprising: what are we waiting for?

But what are they? Monoclonal antibodies are identical “copies” of antibodies – produced in the laboratory – identified in patients recovering from Covid 19. They are “biological weapons”, molecules naturally present in our body with which the drug is produced capable of neutralizing the virus. Researchers isolated antibodies from recovering patients and identified those who have best “neutralized” Sars Cov 2 by joining it and preventing it from replicating. They then produced these antibodies in the laboratory. Monoclonals have worked in the past Ebola and therefore, the goal was to replicate that success.

The drug of Eli lilly authorized in the US a month ago, it was intended for the treatment of adults and children 12 years and older with a positive Covid-19 test, who are at high risk of progressing to serious illness or being hospitalized. It should be given “as soon as possible” and within 10 days of the onset of symptoms. FDA clearance allowed the emergency distribution and use of the drug that is administered through a single intravenous infusion. The treated patients showed “a reduced viral load and a reduction in symptoms and hospitalization rates,” according to the company. And since the beginning of their use, they have reduced the risk of serious disease by 75-90%.