Anti Covid monoclonals: facts, names and controversies
Those who appreciate and those who criticize Aifa's green light to use the monoclonal antibodies of Regeneron and Eli Lilly
In Italy Aifa has authorized the use of the monoclonal antibodies developed in Regeneron and Eli Lilly. They cost around $ 1,200 per dose and are intended only for people at risk after being infected.
And while Walter Ricciardi, consultant to the Minister of Health Roberto Speranza, appreciates the step forward in the fight against Covid, Andrea Crisanti, director of the Laboratory of Microbiology and Virology of the Padua hospital and professor of Microbiology, is convinced that the use of these drugs represent only a waste of money.
WHAT AIFA HAS DECIDED
In recent days, the Technical-Scientific Commission of the Italian Medicines Agency has given the green light to the use, conditional on the treatment of the monoclonal antibodies casirivimab / imdevimab, developed and produced in collaboration by Regeneron Pharmaceuticals and La Roche, and of the antibodies monoclonal bamlanivimab and etesevimab, developed by Eli Lilly.
The drugs, as decided by Aifa, can only be administered to patients at high risk of developing severe forms of the disease, with possible fatal outcomes. Early stage patients should be selected
A HURRY DECISION?
That the green light represents a hasty decision ?, asks the Corriere della Sera to Nicola Magrini, Director General of the Italian Medicines Agency, noting that Aifa has defined the data on monoclonal antibodies as "immature".
“Monoclonal antibodies are potentially promising for a certain type of well-defined patient, so it was decided to open up their use on an exceptional and temporary basis”, replies Magrini. “It's not a green light, it's not a full approval. It is up to the EMA to approve and subsequently to Aifa to establish the reimbursement and therapeutic role of these rapidly evolving drugs, also in light of the ongoing clinical trials that we are also promoting ”.
WALTER RICCIARDI CELEBRATES THE NEW ANTI COVID WEAPON
And if it is not full approval, it is still a step forward to celebrate for Walter Ricciardi, advisor to the Minister of Health. “Now the commissioner structure will be able to start ordering monoclonals. The approval result has been achieved and the next step is to make the best use of these therapies, ie in an appropriate and timely manner, ”said Ricciardi.
NO ORDER
This enthusiasm, however, is dampened by the facts. Eli Lilly said that no pre-orders have come from the Italian government, Ansa reports .
ELI ILLY READY
The Latina-based company BSP Pharmaceuticals, manufacturer of monoclonal antibodies for Eli Lilly, is in any case keeping itself ready and however makes it known that the "production capacity of the plant, if necessary, could be increased". For now, BSP has started the production of 2 million vials of Bamlanivimab destined for the US and foreign markets.
CHRISANTS: WASTE MONEY
Andrae Crisanti, director of the microbiology laboratory of the University of Padua, does not like the green light, conditional and limited, by Aifa for monoclonal antibodies. “I think it's an unprecedented waste of money. In the presence of a vaccine, spend 2-4 thousand euros for a monoclonal antibody without any data demonstrating that they are able to prevent serious infection, then there is the Eli Lilly trial that shows that in severe patients they are counterproductive , I think it's wrong ”, says Crisanti, speaking on Today is another day , on Rai Uno.
THE WORDS OF SILVESTRI
Guido Silvestri, a lecturer in the USA at Emory University in Atlanta, responds to the controversy of Crisanti.
“They tell us to avoid controversy between experts, because they create confusion among the public. In principle, I agree with this principle, but the statements of my colleague Crisanti are really scientifically inexplicable, and create unnecessary confusion on a subject that is already quite complex and polarized ”, says Silvestri, according to Fanpage . “Suffice it to remember that the Germans, certainly not known for their waste of money, have just bought antibodies for 200 million Euros (not to mention Americans, Canadians, and Israelis). Said with great respect but just as clearly, these statements are paired with those of a few months ago, in which the same colleague argued that vaccines against Covid were risky because, according to him, there were no field tests ".
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/monoclonali-anti-covid-fatti-nomi-e-polemiche/ on Tue, 09 Feb 2021 10:38:18 +0000.