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French pharmaceutical giant Sanofi announced in a press release that the experimental treatment based on the drug Kevzara in seriously and critically ill patients suffering from COVID-19 – infection caused by SARS-CoV-2 coronavirus – it did not give the expected benefits, so it was decided not to carry out more clinical trials. Kevzara, trade name of the active ingredient Sarilumab, is a monoclonal antibody immunosuppressant and anti-inflammatory designed to combatrheumatoid arthritis, and was also considered very promising against COVID-19 for its ability to fight against cytokine interleukin-6 (IL-6). In fact, one of the most dangerous complications of coronavirus infection is a disproportionate response from immune system, with an excessive production of cytokines, the so-called “cytokine storm”, which can cause damage and failure in many organs, up to the death of the patient.
For this reason, the therapeutic protocols for the treatment of patients with COVID-19 have included several drugs based on the same principle of action as Sarilumab, in “compassionate use” and “off label”. Today the cold shower of the Sanofi press release, linked to the unsatisfactory results of a study of Phase 3 performed on 420 patients from numerous countries, including Italy. “Kevzara® (sarilumab) given intravenously at a dose of 200 mg or 400 mg to seriously or critically ill hospitalized patients with COVID-19 did not meet its key primary and secondary endpoints when Kevzara was compared with placebo added to the normal hospital care, ”the French pharmaceutical company statement reads.“ Although this study did not produce the desired results, we are proud of the work the team has done to deepen our understanding of the potential use of Kevzara in the treatment of COVID- 19, “said Professor John Reed, head of Sanofi’s department of research and development.
The pharmacist noted that some benefits were found, although not statistically significant, such as the reduction of days of hospitalization and better clinical results achieved faster. Furthermore, “a trend towards reduced mortality was observed in the critically ill group that was not observed in the seriously ill group,” the press release reads. Finally, it is reported that “serious adverse events have been reported from 26-29 percent of Kevzara patients and 24 percent of placebo patients,” while “serious infections (including COVID-19 pneumonia ) in 11-13 percent of Kevzara patients and 12 percent of placebo-treated patients. “
In light of all these results, no further Kevzara-based clinical trials will be conducted by either Sanofi or Regeneron, as indicated. Sanofi’s communication comes a couple of weeks after the publication of the study “Results and analysis of biomarkers in COVID-19 patients treated with sarilumab, an interleukin-6 receptor antagonist (IL-6), in a single institution in Italy” , conducted by Italian scientists, in which, on the other hand, some benefits were noted. Specifically, researchers coordinated by the National Cancer Institute IRCCS Pascale Foundation of Naples oncologist Paolo Antonio Ascierto had shown an improvement in clinical symptoms in 10 of 15 patients treated with sarilumab, finding greater efficacy in those who were not yet intubated. In a Facebook post, Professor Ascierto had stated that “anti-interleukin-6 under the skin can work”, especially in non-intubated patients. The phase 3 study that led Sanofi to withdraw the Kevzara trial, as specified, was instead conducted in critically ill and critically ill patients.
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