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Green light for monoclonal antibodies in Italy. The Technical Scientific Commission of AIFA awarded authorization to use two antibodies monoclonals with some limitations in their use in line with those of Canada and the FDA in the United States: they can be administered, at an early stage, at a limited category of high-risk patients evolution of Covid-19 disease. The approved drugs are those made by Regeneron and Eli Lilly. Monoclonals are considered by the scientific community as a great hope against the Covid pandemic. “A lifesaver” was defined by the president of Aifa, Giorgio Palù, in an interview with Messenger Service. The “rapid start of monoclonal experimentation (“a shot in the arm for the system») The president of the National Federation of Medical Orders, Filippo Anelli, also expected it:« hospitalizations are reduced and clinical results are improved. It can be a strategy to carry out the vaccination campaign in a more flexible schedule.
What are they and how do they work
Monoclonals are drugs that have been used for some time in the treatment of cancer. In recent years they have also been used against some infectious diseases, such as Ebola and now against Sars-CoV-2. They are used to treat those who are already sick., providing the patient already formed antibodies and immediately active against the virus. But how do these drugs work? «They block, in a very powerful way, the entry of the virus into the cell. The final effect is lto neutralization of infectivity of Sars-CoV-2 as shown by numerous scientific studies published in prestigious journals such as Nature, Cell me Science »says Palù. A very promising field of research in which world-renowned universities have also invested: today they are sand antibodies in the final phase of the assay or already authorized including the so-called Trump Cocktail with which the former president of the United States was treated.
Approval before the EMA
Monoclonals are already used in several countries (USA, Canada, Germany, Israel and Hungary) and the Italian approval precedes that of the European Agency. «An emergency measure that authorizes the temporary distribution of monoclonals for which, at the moment, the marketing authorization has not been issued by Ema – explains Palù -. The daily contribution of human lives that Italy still pays today and the difficulty of foreseeing the possibility of obtaining herd immunity cThe administration of vaccines pushes us to consider an integrated preventive approach and effective therapies. Monoclonal, in fact “reduce the risk of hospitalization by 72-83%, if taken early in the disease, 72 hours after the onset of symptoms, when the viral load is maximum, otherwise they are useless“Some have shown” 70% protection against mortality and / or hospitalization. ”
How much they cost
An infusion of monoclonal antibodies costs between 1,000 and 2,000 euros. A justified expense? “A single administration is enough – explains Palù – We would save on hospital expenses: an ordinary hospitalization costs more than 1,000 euros a day, a place in intensive care five times more”. In addition, these drugs act on viral load and make the recipient unable to infect. “ They can be prescribed to patients who, due to age or the presence of other diseases, are at increased risk of infection progression. Preferably for those with mild to moderate symptoms that are followed at home. So many hospitalizations would be avoided“And the side effects?” They are drugs with an excellent safety profile. The risk of serious side effects is practically comparable to that of placebo, “continues Palù.
February 3, 2021 (change February 3, 2021 | 19:40)
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