FDA Accepts Sanofi Pasteur's Application to Expand Indication of Menactra® Vaccine to Infants and Toddlers
New Indication Seeks to Help Protect Infants and Toddlers Against Meningococcal Disease
SWIFTWATER, Pa., Aug. 26 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for use of Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) for active immunization of infants and toddlers for the prevention of invasive meningococcal disease caused by serogroups A, C, Y, and W-135.
Menactra vaccine was the first quadrivalent conjugate vaccine licensed in the United States to help protect against meningococcal disease, a rare but serious disease that can take the life of a child within 24 hours. Menactra vaccine is currently indicated for active immunization of individuals two through 55 years of age and is designed to help offer protection against four serogroups of Neisseria meningitidis (A, C, Y, and W-135), the bacterium that causes meningococcal infection.
The filing is based on results of one Phase II and three Phase III, open-label, controlled, multicenter trials, in which more than 3600 infants and toddlers from the United States received Menactra vaccine using a 2 dose schedule at 9 months and 12 months of age. At 12 months Menactra vaccine was given concomitantly with either measles-mumps-rubella-varicella vaccine (MMRV), pneumococcal conjugate vaccine (PCV7), or Hepatitis A vaccine (HepA). Results from the clinical studies show that a dose of Menactra vaccine at 9 and 12 months of age elicits a robust immune response against the serogroups included in the vaccine. Responses to the concomitantly administered vaccines were equally robust. Vaccine related reactions were similar to those described for other infant vaccines including swelling and tenderness at the site of vaccination, as well as irritability. Most of these side effects were mild and of short duration.
"Sanofi Pasteur is committed to evaluating Menactra vaccine in different age groups in an effort to provide the broadest protection against meningococcal disease," said Michael Decker, MD, MPH, vice president, scientific and medical affairs at sanofi pasteur. "Sanofi Pasteur's meningococcal vaccination approach, focusing on later infancy and the early second year of life, will require only half the doses of an early infant toddler strategy."
About Menactra® Vaccine
Menactra (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) is the only U.S. licensed conjugate vaccine for persons two through 55 years of age for active immunization against invasive meningococcal disease caused by N meningitidis serogroups A, C, Y, and W-135. Since 2005 when it was first licensed in the U.S., more than 32 million doses of Menactra vaccine have been distributed.
A vaccine industry leader, Sanofi Pasteur has a strong heritage of meningococcal vaccine development. Meningococcal vaccines designed to help protect against serogroups A and C were introduced in the mid-1970s. In 1981, Menomune®-A/C/Y/W-135 (Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined) became the first meningococcal vaccine available to help protect against meningococcal disease caused by four of the five most common serogroups (A, C, Y and W-135).
In 2005, Menactra vaccine was granted FDA licensure and became the first quadrivalent meningococcal conjugate vaccine available in the U.S. for those 11-55 years of age. Two years later the age indication was extended down to the age of two years.
Side effects following administration of Menactra vaccine include: pain, redness, and swelling at the injection site, as well as headache and fatigue. Other side effects may occur. Vaccination should be avoided by persons with known hypersensitivity (severe allergic reaction) to any ingredient of the vaccine, including latex (which is used in the vial stopper), or by any persons previously diagnosed with Guillain-Barre syndrome. Vaccination with Menactra vaccine may not protect all individuals.
For more information about Menactra vaccine, go to www.menactra.com
About Meningococcal Disease
Meningococcal disease, which includes meningitis, is a serious bacterial infection that strikes between 1,000 to 2,600 Americans each year. Approximately 10 percent of individuals who contract meningococcal disease will die. Of those who survive, up to one in five suffer permanent disabilities such as hearing loss, neurological damage and limb amputations. Meningococcal disease can be hard to recognize, especially in its early stages, because symptoms are similar to those of more common viral illnesses. Unlike more common illnesses, the disease can progress quickly and may cause death or disability in just a single day.
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). For more information, please visit: www.sanofi-aventis.com
Sanofi Pasteur, the vaccines division of sanofi-aventis Group, provided more than 1.6 billion doses of vaccine in 2009, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers the broadest 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-aventis' 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-aventis, 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 products candidates, the absence of guarantee that the products 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 as well as those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2009. Other than as required by applicable law, sanofi-aventis 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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