PARIS (dpa-AFX) - Sanofi (SNYNF, SNY) announced Tuesday that the Phase 3 trial of Kevzara (sarilumab) did not meet its primary endpoint and key secondary endpoint in COVID-19 patients outside the U.S.
The global Phase 3 trial investigating intravenously administered Kevzara at a dose of 200 mg or 400 mg in severely or critically ill patients hospitalized with COVID-19 failed to meet its goals when Kevzara was compared to placebo added to usual hospital care.
The 420-patient randomized trial was conducted outside the U.S. in Argentina, Brazil, Canada, Chile, France, Germany, Israel, Italy, Japan, Russia and Spain.
In the trial, although not statistically significant, numerical trends were observed toward a decrease in duration of hospital stay as well as an acceleration in time to improve clinical outcomes. The time to discharge was shortened by 2-3 days in the patients treated with Kevzara within the first two weeks of treatment.
Serious adverse events were experienced by 26-29% of Kevzara patients and 24% of placebo patients. The incidence of adverse events leading to death was approximately 10% in all three treatment arms.
The company plans to submit detailed results to a peer-reviewed publication later this year.
At this time, Sanofi and Regeneron do not anticipate conducting further clinical studies for Kevzara in COVID-19.
Kevzara is currently approved in multiple countries to treat adults with moderately to severely active rheumatoid arthritis who have not responded to or tolerated previous therapy.
Copyright RTT News/dpa-AFX
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