Le Lézard
Classified in: Health
Subject: FDA

FDA approves Dengvaxia® for the prevention of dengue in individuals ages 9 through 16 living in U.S. endemic areas

BRIDGEWATER, N.J., May 1, 2019 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) approved Dengvaxia® (Dengue Tetravalent Vaccine, Live) for the prevention of dengue disease caused by serotypes 1 ? 4 of the virus in individuals 9 through 16 years of age living in endemic areas of the U.S. with a laboratory-documented prior infection. Dengvaxia is the first and only vaccine approved for protection against dengue in endemic areas of the U.S.

"Dengue is endemic and prone to outbreaks in several U.S. territories, including Puerto Rico, the U.S. Virgin Islands and American Samoa. Despite this public health threat, there is no treatment and there has been no previously approved vaccine available in these areas," said David Greenberg, MD, Regional Medical Head North America, Sanofi Pasteur. "Today's FDA approval of Dengvaxia allows us to bring a critical medical prevention tool to at-risk populations, helping combat and prevent dengue among children living in U.S. dengue endemic areas."

Dengvaxia is also approved for use in several endemic countries in Latin America and Asia where reducing the human and economic burden of dengue is a public health priority. In December 2018, the European Commission granted marketing authorization for Dengvaxia to prevent dengue in individuals living in endemic areas with a documented prior infection.

Indication for Dengvaxia® (Dengue Tetravalent Vaccine, Live)
Dengvaxia is a vaccine given to people 9 through 16 years of age to help prevent dengue infection due to dengue virus serotypes 1, 2, 3 and 4. Dengvaxia should only be given to people who have previously had a dengue infection, and live in areas where dengue is endemic.

Your child should not receive Dengvaxia if he or she has not had a previously confirmed dengue infection, or if this information is unknown. People who have not had a previous dengue infection are at increased risk for severe dengue when vaccinated with Dengvaxia and later infected with a dengue virus. Previous dengue infection can be verified by a medical record of a previous laboratory confirmed dengue infection, or by testing for dengue before vaccination.

It is unknown whether Dengvaxia is safe or protective for people living in areas where dengue is not endemic who travel to dengue endemic areas.

Important Safety Information for Dengvaxia (Dengue Tetravalent Vaccine, Live)
Dengvaxia vaccine should not be given to anyone with a history of severe allergic reaction to a previous dose of Dengvaxia or to any component of Dengvaxia. 

Dengvaxia should not be given to people with a severely suppressed or compromised immune system.

Before your child can receive Dengvaxia, your child's health care professional must determine whether your child has had a confirmed dengue infection.

Currently, no available tests have been cleared by the Food and Drug Administration (FDA) to determine a previous dengue infection. Talk with your health care professional about available tests. For the month after receiving Dengvaxia, tuberculosis skin tests may be falsely negative. If you undergo tuberculosis skin testing in the month after vaccination, tell the health care professional performing the test that you received Dengvaxia.

The most common side effects of Dengvaxia include headache, pain at the injection site, general discomfort, tiredness, and muscle aches. Other side effects can occur. 

It is recommended to continue personal protection measures against mosquito bites after vaccination since vaccination with Dengvaxia may not protect all people. 

Please see the full Prescribing Information for Dengvaxia (Dengue Tetravalent Vaccine, Live).

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

Media Relations Contact
Nicolas Kressmann
Tel.: +1 732-532-5318

Investor Relations Contact
George Grofik
Tel.: +33 (0)1 53 77 45 45

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 regarding the marketing and other potential of the product, or regarding potential future revenues from the product. 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, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the absence of guarantee that the product will be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic conditions, as well as those risks 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, 2018. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Source: Sanofi (EURONEXT: SAN) (NASDAQ: SNY)


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News published on 1 may 2019 at 18:35 and distributed by: