Sanofi Pasteur Announces FDA Approval of Updated Prescribing Information for Fluzone® High-Dose Vaccine for Adults 65 and Older

SWIFTWATER, Pa., Nov. 3, 2014 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN andNYSE: SNY), today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental biologics license application (sBLA) for Fluzone^® High-Dose (Influenza Vaccine) to include efficacy data in the Prescribing Information. These data demonstrate that Fluzone High-Dose vaccine provided improved protection against influenza ("the flu") compared to standard-dose Fluzone vaccine (trivalent intramuscular formulation) in adults 65 years of age and older. 

The Prescribing Information for Fluzone High-Dose vaccine now includes data from a large-scale, multi-center efficacy and safety trial published in the August 14, 2014, issue of The New England Journal of Medicine (DOI: 10.1056/NEJMoa1315727).[i]

The study found Fluzone High-Dose vaccine was 24.2 percent (95% CI, 9.7 to 36.5) more effective than standard-dose Fluzone vaccine in preventing laboratory-confirmed influenza caused by any influenza viral type or subtype in association with influenza-like illness, the primary endpoint. This indicates that about one in four breakthrough cases of influenza could be prevented if Fluzone High-Dose vaccine were used instead of the standard-dose Fluzone vaccine in the 65 and older population.

"Inclusion of these efficacy data in the Fluzone High-Dose vaccine Prescribing Information validates the importance of this vaccine for people 65 years of age and older," said David P. Greenberg, M.D., Vice President, Scientific & Medical Affairs, and Chief Medical Officer, Sanofi Pasteur US. "We are fully committed to helping protect patients from influenza, and we urge everyone eligible—especially older adults—to get vaccinated as soon as possible if they have not already done so."

Fluzone High-Dose vaccine is an inactivated influenza vaccine that contains four times the amount of antigen (60 mcg hemagglutinin [HA] per strain) than is contained in standard-dose Fluzone vaccine (15 mcg HA per strain). Post-vaccination, Fluzone High-Dose vaccine induces higher antibody responses compared to standard-dose Fluzone vaccine. In response to the unmet medical need in older adults, Fluzone High-Dose vaccine was licensed by the FDA in December 2009 under the agency's accelerated approval process. Licensure was based on the vaccine's safety profile and superior immunogenicity compared to standard-dose Fluzone vaccine. Immunogenicity (the ability of a vaccine to trigger the body to produce antibodies against an infectious agent) is commonly used to evaluate vaccines in clinical trials.

"We look forward to further discussing these data with the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices and other health policy-makers," said Phil Hosbach, Vice President, New Products and Immunization Policy, Sanofi Pasteur. "Given the significance of these results, we believe that Fluzone High-Dose vaccine fills a vital public health need as the only influenza vaccine shown specifically to address the age-related decline of the immune system. Compared to younger adults, people 65 years of age and older suffer disproportionately from seasonal influenza and its complications, including severe illness leading to hospitalization and death."

Adults aged 65 and older typically account for more than half (60 percent) of influenza-related hospitalizations and almost all (90 percent) of influenza-related deaths.[ii] Studies have shown people aged 65 years and older do not respond to standard-dose influenza vaccine as well as younger adults and may be left without sufficient protection,[iii] especially against influenza A/H3N2, which is considered the most burdensome in older adults.[iv][v]

About the Efficacy Study 
This study was a multi-center, double-blind post-licensure efficacy trial conducted in the United States and Canada in which adults 65 years of age and older were randomized (1:1) to receive either Fluzone High-Dose vaccine or Fluzone vaccine. The study was conducted over two influenza seasons (2011-2012 and 2012-2013).

The study compared the efficacy and safety profiles of Fluzone High-Dose vaccine to those of Fluzone vaccine. The per-protocol analysis set for efficacy assessments included 15,892 Fluzone High-Dose vaccine recipients and 15,911 Fluzone vaccine recipients. The primary endpoint of the study was the occurrence of laboratory-confirmed influenza (as determined by culture or polymerase chain reaction) caused by any influenza viral type/subtype in association with influenza-like illness (ILI), defined as new onset (or exacerbation) of at least one of the following respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing; concurrent with at least one of the following systemic signs or symptoms: temperature greater than 99.0 degrees F (37.2 degrees C), chills, tiredness, headaches or myalgia.

A secondary endpoint of the study was the occurrence of culture-confirmed influenza caused by viral types/subtypes antigenically similar to those contained in the vaccines in association with a modified CDC-defined ILI, defined as the occurrence of a temperature greater than 99.0 degrees F with cough or sore throat. The efficacy of Fluzone High-Dose vaccine relative to Fluzone vaccine for this endpoint was 51.1 percent (95% CI, 16.8 to 72.0).

The safety analysis set included 15,992 Fluzone High-Dose vaccine recipients and 15,991 Fluzone vaccine recipients. Within the study surveillance period (approximately six to eight months post-vaccination), 1,323 (8.3 percent) Fluzone High-Dose vaccine recipients and 1,442 (9.0 percent) Fluzone vaccine recipients experienced a serious adverse event (SAE). Within 30 days post-vaccination, 204 (1.3 percent) Fluzone High-Dose vaccine recipients and 200 (1.3 percent) Fluzone vaccine recipients experienced an SAE. The majority of these participants had one or more chronic comorbid illnesses. A total of 167 deaths were reported within six to eight months post-vaccination: 83 (0.5 percent) among Fluzone High-Dose vaccine recipients and 84 (0.5 percent) among Fluzone vaccine recipients; no deaths were considered by the investigators to be related to vaccination.

About Fluzone High-Dose (Influenza Vaccine) Indication
Fluzone High-Dose vaccine is indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B virus contained in the vaccine.

Fluzone High-Dose vaccine is approved for use in persons 65 years of age and older.  

Safety Information
The most common local and systemic adverse reactions to Fluzone High-Dose vaccine include pain, erythema, and swelling at the injection site; myalgia, malaise, headache, and fever. Other adverse reactions may occur. Fluzone High-Dose vaccine should not be administered to anyone with a known hypersensitivity (eg, anaphylaxis) to any vaccine component, including egg protein, or to a previous dose of any influenza vaccine.

If Guillain-Barre syndrome has occurred within 6 weeks following previous influenza vaccination, the decision to give Fluzone High-Dose vaccine should be based on careful consideration of the potential benefits and risks. Vaccination with Fluzone High-Dose vaccine may not protect all individuals.

Before administering Fluzone High-Dose vaccine, please see accompanying full Prescribing Information.

About Sanofi
Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi Pasteur, the vaccines division of Sanofi, provides more than 1 billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers a broad range of vaccines protecting against 20 infectious diseases. The company's heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR 1 million in research and development. For more information, please visit: www.sanofipasteur.com or www.sanofipasteur.us

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, the Group's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies 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, 2013. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

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SOURCE Sanofi Pasteur

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