(AOF) – Sanofi and Regeneron Pharmaceuticals announced last night that the Phase III trial of Kevzara (sarilumab) 400 mg in the United States in patients with Covid-19 infection requiring mechanical ventilation has not reached its target. primary and secondary endpoints when Kevzara was added to best supportive care, compared to best supportive care only (placebo).
Based on these results, the trial in the United States was stopped, including in a second cohort of patients treated with a higher dose of Kevzara (800 mg).
The detailed results of this trial, partially funded by the United States, will be submitted to a peer-reviewed scientific publication later this year.
A separate trial, piloted by Sanofi and based on a different dosage regimen, is currently being conducted outside the United States in patients hospitalized for a severe and critical form of Covid-19.
The trial conducted by Regeneron in the United States and that conducted by Sanofi outside the United States are supervised by the same independent committee responsible for monitoring the data. He recommended continuing the trial outside the United States. Sanofi and Regeneron plan to report results for the third quarter of 2020.
FDA (Food and Drug Administration)
Among the attributions of the Food and Drug Administration (the sanitary authorities in the United States) one counts in particular the delivery of the authorizations to place on the market of the whole of the drugs intended for this country, which represents the first world market for the ‘pharmaceutical industry.
Clinical trials (Phases I, II, III)
Phase I: small-scale test of the molecule on humans to assess its safety, tolerance, metabolic and pharmacological properties.
Phase II: evaluation of tolerance and efficacy in several hundred patients to identify side effects.
Phase III: evaluation of the overall benefit / risk ratio with several thousand patients.
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