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The “failed trial“Revealed by Done ends this morning at the table of an urgent meeting of theAifa, the pharmaceutical agency that in October rejected the free trial proposal for Bamlanivimab (LY-CoV-555), the neutralizing monoclonal antibody developed by the multinational Eli lilly and produced in Italy. And on that table, the path to monoclonals in use abroad could reopen in a very short time, until now left on deaf ears.
The new president of the anti-drug agency put it on the agenda Giorgio Palù, which confirms it to Done. In the period in which the experiment was proposed and canceled, between October 7 and 29, he was still in the role of the world-famous virologist and already publicly supported the need for Italy to look closely not only at vaccines but also Antibody therapies experimented abroad with promising results. As we have said, 10,000 doses were offered to Italy at the beginning of October: free and produced here.
Our country, already crushed by the second wave, could have been the first in Europe to experience it, giving the sick the only authorized treatment in the world against Covid. The drug reduces viral load and for high-risk patients it reduces hospitalizations by 72%: in proportion to the vials, at least 950 hospitalizations would have been saved.
Now we want to understand based on what scientific and regulatory evaluations it was decided to archive it. Who objected? Why? Bamlanivimab has been used for a month and a half in the United States with encouraging results. Experimentation in Italy could have confirmed the doubts of Italian experts, or show that the drug is more effective than the Tachipyrine that Aifa recommends to non-hospitalized patients. According to the Fact, at the key meeting on October 29 between the multinational, Aifa, ISS and Cts, he set out not to dwell on the results of research conducted on limited samples, but to use clinical data from the US hospitals that were already administering it. On the regulatory front, it now seems certain that it was not necessary to wait for authorization from the EMA.
In Italy a specific law was enacted: 648/96 allows the use of medicines not authorized by the EMA for which there is no alternative therapy. It happened in 2005, for example, with Trastuzumab (breast cancer), another monoclonal. The necessary condition, says the law, is that there are “completed studies, at least in phase II, that demonstrate adequate efficacy with an acceptable risk profile to support the requested indication.” In the case of Eli Lilly’s drug, these conditions are there. “They are very important drugs,” says the president of the Italian Society of Pharmacology, Giorgio Raccagni. “They are effective if they are administered early to high-risk patients because they considerably reduce the viral load and consequently the hospitalizations that saturate hospitals. I trust that Aifa will make a decision in the direction of other European countries ”. This would also be the direction of Minister Speranza who has never been embargoed on the monoclonal route, not only sponsoring the Italian one under study but also towards those developed abroad.
The paradox is that the minister signed a formal expression of interest in the purchase by Italy in a meeting with the multinational -also present Arcuri- on November 16, when the option of 10,000 doses had already been abandoned. free. Its value was 10 million euros, which we could have saved along with many lives.
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