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The companies provided an update stating that the biologic did not meet a primary endpoint in a Phase III clinical trial when compared with placebo in the treatment of COVID-19 patients.
On Sept. 1, 2020, Sanofi and Regeneron Pharmaceuticals provided an update on the potential use of the anti-arthritis biologic, Kevzara (sarilumab), to treat COVID-19. The companies reported that the drug did not meet its primary endpoint and a key secondary endpoint when compared to placebo in a global Phase III trial investigating Kevzara’s use as an intravenous treatment for severely or critically ill COVID-19 patients. In the trial, Kevzara was intravenously administered at doses of 200 mg or 400 mg. The Phase III trial was conducted outside the United States in Argentina, Brazil, Canada, Chile, France, Germany, Israel, Italy, Japan, Russia, and Spain.
Presently, Sanofi and Regeneron do not anticipate conducting further clinical studies for Kevzara in COVID-19 treatment.
The numerical trends in the Phase III study were not statistically significant but were observed to be moving toward a decrease in duration of hospital stay as well as an acceleration in time to improve clinical outcomes. This was measured by a two-point improvement from baseline on a seven-point scale. A trend was further observed towards reduced mortality in the critical patient group. This trend was not observed in the severe patient group. In addition, the time that passed before discharge from the hospital was shortened by two to three days (statistically non-significant) in the patients who treated were with Kevzara within the first two weeks of their treatment regimen, according to Sanofi in a company press release.
Approximately 26%–29% of Kevzara patients and 24% of placebo patients experienced serious adverse events. The incidence of adverse events that led to death was approximately 10% in all three treatment arms. Meanwhile, serious infections (including COVID-19 pneumonia) were observed in 11%–13% of Kevzara patients and 12% of placebo patients. Sanofi plans to submit detailed results in a peer-reviewed publication later this year.
“Although this trial did not yield the results we hoped for, we are proud of the work that was achieved by the team to further our understanding of the potential use of Kevzara for the treatment of COVID-19,” said John Reed, MD, PhD, global head of Research and Development, Sanofi, in the press release. “In times like these, commitment to properly designed, controlled clinical trials, provides the information and understanding the scientific community needs for fact-based decision making. At Sanofi, we are committed to help combat the global COVID-19 pandemic, including developing vaccine candidates that can be manufactured at large-scale.”
Kevzara is currently approved in multiple countries for treating moderately to severely active rheumatoid arthritis in adults who have not responded to or tolerated previous therapy.