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FDA Grants Priority Review for Sanofi’s Dengue Vaccine Candidate

FDA Grants Priority Review for Sanofi’s Dengue Vaccine Candidate

Treatment for Prevention of Dengue

FDA Grants Priority Review for Sanofi’s Dengue Vaccine Candidate

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.

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.

Sanofi Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation,  trends in exchange rates and prevailing interest rates, volatile economic conditions, the impact of cost containment initiatives and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2017. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

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.

SOURCE Sanofi

 

Posted: October 2018

Dengvaxia (dengue vaccine) FDA Approval History

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