Sanofi provides update on Kevzara® (sarilumab) Phase 3 trial in severe and critically ill COVID-19 patients outside the U.S....
01 Setembro 2020 - 2:00AM
PARIS – September
1, 2020 – Sanofi today announced that the global Phase 3
trial investigating intravenously administered
Kevzara® (sarilumab) at a dose of 200 mg or 400 mg[a] in
severely or critically ill[b] patients hospitalized with
COVID-19 did not meet its primary endpoint and key secondary
endpoint[c] 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 (86 in placebo, 161
in 200 mg, and 173 in 400 mg arms).
“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, M.D., Ph.D., Global
Head of Research and Development, Sanofi. “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.”
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, as measured by a 2-point improvement from
baseline on the 7-point scale. Further, a trend was observed
towards reduced mortality in the critical patient group which was
not seen in the severe patient group. Finally, the time to
discharge was shortened by 2-3 days (statistically non-significant)
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. Serious infections (including COVID-19
pneumonia) were observed in 11-13% of Kevzara patients and 12% of
placebo patients.
Detailed results will be submitted 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.
About Kevzara® (sarilumab)
Injection
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.
Kevzara binds specifically to the IL-6 receptor
and has been shown to inhibit IL-6 mediated signalling. IL-6
is an immune system protein produced in increased quantities in
patients with rheumatoid arthritis and has been associated with
disease activity, joint destruction and other systemic
problems.
[a] The protocol initially prescribed a single
infusion, and subsequently amended to allow a second infusion of
the randomly assigned treatment 24-48 hours after the initial
infusion if clinical deterioration or no improvement was observed
according to protocol-defined criteria.[b] Severe disease:
requires oxygen by nasal cannula, simple face mask, or other
similar oxygen delivery device. Critical disease: requires
oxygen by non-rebreather mask or high-flow nasal cannula, or use of
invasive or non-invasive ventilation, or treatment in an
intensive care unit.[c] The primary endpoint was time to
improvement of 2 points or greater on a 7-point clinical scale
(where 1=death; 2=hospitalized, on invasive mechanical ventilation
or extracorporeal membrane oxygenation;3=hospitalized, on
non-invasive ventilation or high flow oxygen devices;
4=hospitalized, requiring supplemental oxygen; 5=hospitalized, not
requiring supplemental oxygen - requiring ongoing medical care
(COVID-19 related or otherwise); 6=hospitalized, not requiring
supplemental oxygen - no longer requires ongoing medical care;
7=not hospitalized). The key secondary endpoint was
percentage of patients alive at Day 29.
About Sanofi Sanofi is dedicated to
supporting people through their health challenges. We are a global
biopharmaceutical company focused on human health. We prevent
illness with vaccines, provide innovative treatments to fight pain
and ease suffering. We stand by the few who suffer from rare
diseases and the millions with long-term chronic
conditions. With more than 100,000 people in 100 countries,
Sanofi is transforming scientific innovation into healthcare
solutions around the globe. Sanofi, Empowering Life |
Sanofi Media Relations Contact Sally Bain Tel: +1
(781) 264-1091 sally.bain@sanofi.com |
Sanofi
Investor Relations Contacts Paris Eva Schaefer-Jansen
Arnaud DelepineYvonne Naughton Sanofi Investor
Relations Contacts North America Felix LauscherFara
BerkowitzSuzanne Greco IR main line:Tel.: +33 (0)1 53 77 45 45
ir@sanofi.com |
Sanofi
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