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, 2019.
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.
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.
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Posted: October 2018
Dengvaxia (dengue vaccine) FDA Approval History
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