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“The toll of victims that we pay every day” to the Sars-CoV-2 coronavirus “could not make us wait. It was one of the reasons for giving the green light to monoclonal antibodies and I found the sensitivity of the Minister of Health, Roberto Speranza.” . The president of the Italian drug agency Aifa, Giorgio Palù, thus explains to Adnkronos Health the value of the authorization granted to the use of monoclonal antibodies, those produced by Regeneron and Eli Lilly, for the treatment of Covid-19 under specific conditions.
“There was some reason for reflection because the European agency Ema has not yet expressed itself – highlights the virologist – In the United States the FDA has authorized the emergency use of these monoclonal antibodies. They will remember the ‘cocktail’ of ‘drugs’ that is used for then-President Donald Trump, who in 24 hours left the hospital. But now there are irrefutable data. What emerges from the papers published in major journals is that they are a powerful weapon if administered in the early stages of infection, at the first symptoms, before the infection progresses. And this is the use that will be made in high-risk patients, with comorbidities and high risk of the infection turning into a serious disease ”.
The president of Aifa also clarifies his “commitment to this initiative. I must say that I depended on the great sensitivity shown by Minister Speranza, from whom I received a reminder and for whom I had prepared a scientific report.” On the research front, we are making progress. “There are several studies on monoclonal antibodies, 6 very advanced, of which a pair in phase 3 nearing completion; about ten in phase 1 and 2. The impact could be significant ”, Palù is convinced.
With the go-ahead for the first two monoclonal antibodies, he continues, “Italy today is like Germany and is ahead in this new therapy. And I would like to thank Speranza who supported me on this front.”
“It is intended for domestic use”
“The significant data that we can see in very important scientific journals tells us that monoclonal antibodies are a powerful weapon if administered at the first symptoms, before the infection with the” Sars-CoV-2 coronavirus “progresses. they should be used both a lot in the hospital, but possibly at home, ”says Palù.
“If we had an efficient and generalized system, like the one some Regions have, we could think of a system that allows home administration with the Usca (Special Care Continuity Units, ed) and also the participation of local clinics that intervene in the first stages of ‘infection with an early diagnosis’, explains the virologist.
“We need a very fast connection between the early diagnosis” of positivity to Sars-CoV-2 “and the information, so that the National Health Service intervenes to guarantee the use of monoclonals in subjects with comorbidities and at risk of infection being become a serious disease, depending on the indication. “
The announcement: “Special fund for monoclonals”
There will be a special fund made available by the commissioner “for anti-Covid monoclonal antibodies,” the president of the Italian pharmaceutical agency Aifa later announces to Adnkronos Health. And in fact, clarifies the virologist, “the mechanism with which it was approved yesterday In the board of directors it is not the law 648/1996 that weighs on the national fund. For the monoclonals there will be an extraordinary fund in terms of vaccines, relying on in legislative decree 219 of 2006, which transposes a European directive of 2003. It is the one that was exploited in 2016 for the Ebola emergency, which fortunately did not give a pandemic unlike Sars-CoV-2. And it is the same legislation used by the German minister Jens Spahn and, from what I have heard, perhaps also by France and Hungary for the emergency use of monoclonals ”.
Palù does not comment on the scope of the extraordinary fund for monoclonals that the commissioner will make available for the Covid emergency. “But it is good to have a special fund, which is not tied to the top of the national fund. There are all the conditions for the use of these therapies. In this way, we will soon be able to buy the monoclonal antibodies for which the green light has been given.” , which are produced by Regeneron and Eli Lilly.
For the fully Italian monoclonal antibody currently being tested, “it will still take months,” explains Palù. Meanwhile, “with yesterday’s go-ahead we already have a weapon to use in the early stages of the infection.”
At the same time, recalls the virologist, “there is a call for research on monoclonal antibodies with a deadline of February 15. It will be reviewed in the light of what has just started: we will be able to evaluate combinations of monoclonal antibodies or verify which is more effective or no. This trend is still alive. Italy today is ahead of the activity launched for these therapies “.
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