What do we know about monoclonal antibodies produced in Italy and not yet used

What do we know about monoclonal antibodies produced in Italy and not yet used

The drug in question is very similar to the one Trump was treated with. Produced in Latina, the antibody is already used in the US and in other countries, but not in Italy where Aifa has not yet expressed itself

(photo: Miguel Á. Padriñán via Pixabay) Where are we now with therapies against the coronavirus? There has often been talk of monoclonal antibodies capable of neutralizing the new coronavirus. Particular attention was paid, also by the media, to the antibody produced in Italy by Bsp Pharmaceuticals in Latina and then developed by the multinational Eli Lilly in the United States. The drug we are talking about is called bamlanivimab or Cov555 and is very similar to that of Regeneron (also US), successfully administered to President Donald Trump.

For now, the bamlanivimab antibody has been found to be effective in partially reducing viral load in mild and moderate cases. At the beginning of October 2020, our country was given the opportunity to experiment with it in a clinical study on 10 thousand patients. But this possibility has not been seized, as Il Fatto Quotidiano tells in an investigation, while since the beginning of October the Italian company has been supplying numerous doses that are sent to countries where the drug is already authorized, as Adnkronos announces. , such as the USA, Canada, Israel and Hungary. In Italy they are not currently used and the Italian Medicines Agency (Aifa) has not yet expressed itself. Here is what we know and the results of the tests on this monoclonal antibody.

How effective is Eli Lilly's antibody

Always intended for oncology, monoclonal antibodies can also be effective against the new coronavirus. The bamlanivimab antibody was studied in a clinical trial conducted in the US and called Blaze-1, phase 2, in which about 450 patients with mild or moderate Covid-19, not hospitalized, were involved. Results from the Phase 2 Blaze-1 clinical trial, published in the New England Journal of Medicine, indicate that there was a slight reduction in symptoms in the monoclonal antibody group and a decrease in hospitalization and access rates. emergency from 6.3% (in the control group taking a placebo) to 1.6% in patients treated with the antibody. These percentages are associated and correspond to the following numbers: 5 hospitalized in the group that received the antibody and 9 in the placebo group. In the conclusions of the study we read that the interim analysis (not conclusive) of the phase 2 trial "one of the three doses administered of the LY-CoV555 antibody seems to accelerate the natural decline in viral load over time, while the others did not this effect on the 11th day ”. Therefore, there is a slight advantage in one of the three treated groups (the one with the intermediate dosage).

Another study, however, indicated a setback in the study of this antibody, especially in patients with Covid- 19 more serious. The Activ-3 trial was in fact suspended by an independent committee due to the absence of significant clinical benefits in hospitalized patients, therefore with more severe forms than those analyzed by the other Blaze-1 study.

What we know about non-use in Italy

Il Fatto Quotidiano has published an investigation into Italy's lack of access to the drug in October 2020 for the possible experimentation on 10 thousand patients. The text reports the opinions of some specialists and scientific protagonists in the unfortunate occasion of the pandemic who wondered the reasons for this slowdown. The drug was produced in Italy, by a company in Latina whose headquarters in Sesto Fiorentino let it be known that the antibody was put into production before the trial was over to facilitate early access - always according to the rules of the regulatory authorities. - as soon as possible. Since November 9, the US Food and Drug Administration (FDA) has granted emergency use authorization (often used in general and already in this pandemic for other drugs and treatments). Since that time, the United States has purchased nearly a million doses. In Europe, the EMA does not provide this possibility of use (emergency), but since 2001 a European directive allows individual EU countries to purchase them.

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monoclonal antibodies Coronavirus Italy United States Covid-19 therapies globalData.fldTopic = "monoclonal antibodies, Coronavirus, Italy, United States, Covid-19 therapies"

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