Covid, Lai (Sobi): “Aifa evaluates the drug anakinra as a cure, the data speak for themselves”

On the use of anakinra against Covid, “we hope that there will be a consideration by Aifa as quickly as possible”, while “from the European Medicines Agency Ema, if there are no further requests, we expect a decision, whether approval or not “” by mid-October “. Sergio Lai, vice president and general manager of Sobi (Swedish Orphan Biovitrum), the multinational biopharmaceutical industry that supported the ‘Save-more’ study, published in Nature, which demonstrates how early treatment with the drug anakinra (already used to treat rheumatoid arthritis and other serious inflammatory diseases) in Covid patients reduce mortality and ICU admissions by 55%. “The application for extension and registration for use also in Covid of the anakinra product, Kineret * commercial name, and which – Lai recalls – has been in use for over 20 years for other purposes and has a very high safety profile, because it is a drug that has natural characteristics, is currently being evaluated by Ema. So – concludes Lai – Ema is following its path with its times, with its evaluation and we are waiting “. “The study that, like Sobi, we supported, is an international trial conducted on 608 patients that involved 28 centers in Greece and 8 of the most important centers in Italy” including the National Institute for Infectious Diseases Spallanzani and the Gemelli Polyclinic in Rome, the San Raffaele in Milan, the Spedali Civili in Brescia and the San Martino in Genoa and “produced extraordinary results. A confirmatory study – explains Lai – carried out at the request of the European Medicines Agency Ema which followed a study Phase 2 always carried out in Greece, in which we followed all the modalities and requests regarding registration: a randomized double-blind study, therefore a very high profile study “. Now, pending the pronouncement of the EMA, “Aifa – underlines the manager Sobi – has the possibility, as already demonstrated in the case of the third dose of the anti-Covid vaccine and in other situations, to be able to make autonomous choices according to those who are validity of data submitted by some experimenters This – he remembers – happened, in the sense that some experimenters had sent requests for approval according to what is the 648 regulation and Aifa decided to decline these requests that had been sent. This decline – Lai specifies, however – had been done with the almost definitive data, not yet with the publication in Nature. What we hope now is that, pending approval by the EMA, Aifa can also evaluate “an autonomous approval. . “As to why Aifa did not do it I will not go into the merits because – affirms the vice president Sobi – all my statements could be speculation, so I am simply on the facts: they believed that at the time of the evaluation there were not all the elements to be able to give an approval “. But “right now – he remembers – we are at the latest publications, the data speak very clearly, the study has given extraordinary results: we are talking about a reduction in mortality between 50 and 80%, a reduction in the progression of the respiratory decay of more than 70%, of the reduction in hospitalization from 4 to 1 day, of more than 50% of patients who can be discharged without viral load. There is no drug in the world, and I say it aloud, that has demonstrated these data”. “These are all extraordinary data – he underlines – and we hope that Aifa can be taken into consideration as quickly as possible. But – the manager explains – I leave the decision to them, everyone has their own task. It is up to us to produce valid data. as we have shown and make them available to the authorities to be able to confront them, to evaluate them in order to give an answer as effective as possible to patients who up to now – he stresses – do not have many opportunities for equally valid treatment “. “On a personal level – concludes Lai – I would like to say that we are too easily accustomed to having 70 deaths a day. Seventy deaths a day means 500 deaths a week, a small Italian village that goes away. I’ll never get used to it. And we believe that a part of these 70 could have been saved, that’s all. “