BRIDGEWATER, N.J., Oct. 30, 2018 /PRNewswire/ -- The United
States Food and Drug Administration (FDA) has accepted a Biologics
License Application for Sanofi Pasteur's dengue vaccine.
The dengue vaccine candidate has been granted priority review by
the FDA as it would represent the first and only medical prevention
tool against dengue, including severe dengue, which is considered
an unmet medical need. The FDA set a Prescription Drug User Fee Act
action date of May 1.
Dengue is endemic in the US territories of Puerto Rico and the US Virgin Islands. In
2010, Puerto Rico experienced the
largest outbreak when more than 12,000 cases were confirmed.
Incidence remained high in subsequent years, particularly in 2012
and 20131,2. Dengue represents a health and economic
burden in Puerto Rico with total
annual associated costs reaching an estimated $160.2 million.3
"Sanofi is committed to
reducing the global burden of dengue," said Dr. David Greenberg, Regional Medical Head
North America, Sanofi Pasteur. "The vaccine has been
evaluated in studies involving more than 40,000 people from 15
countries around the world with up to six years of follow-up data
from large-scale investigations that included Puerto Rico as a study site."
People can get dengue up to four times and dengue is unique in
that the second infection tends to be worse than the first. This
means that prevention of re-infection with another dengue serotype
can help to reduce the individual risk of severe dengue, as well as
the overall healthcare costs associated with hospitalization due to
dengue.
The vaccine, known as Dengvaxia® in countries where
it is approved, remains the only vaccine available for the
prevention of dengue. The European Commission is expected to grant
marketing authorization for Dengvaxia in December 2018.
About Sanofi
Sanofi (EURONEXT: SAN) (NYSE: SNY) is dedicated to supporting
people through their health challenges. We are a global
biopharmaceutical company focused on human health. We help 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
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1 https://www.cdc.gov/dengue/about/inpuerto.html last
accessed December 15, 2016
2 Sharp, Tyler M. et al.
Virus-specific differences in Rates of Disease during the 2010
Dengue Epidemic in Puerto Rico. PLOS Neglected Tropical
Diseases. April 4, 2013.
http://dx.doi.org/10.1371/journal.pntd.0002159
3 Shepard, D.S., et al., The global economic burden of
dengue: a systematic analysis. Lancet Infect Dis, 2016. 16(8): p.
935-41.
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SOURCE Sanofi