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news.Wyeth Pharmaceuticals, a division of Wyeth, has submitted a marketing authorization application to the European Medicines Agency for approval to market its investigational 13-valent pneumococcal conjugate vaccine for infants and young children.
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Wyeth is seeking an indication for the prevention of pneumococcal disease caused by the 13 serotypes included in the investigational vaccine in infants and children from two months to five years of age. The review of the marketing authorization application (MAA) will be coordinated by the European Medicines Agency (EMEA) for all 27 countries in the EU, as well as Norway, Iceland and Liechtenstein.
The PCV13 submission to EU regulators includes data from 12 Phase III studies, involving more than 7,000 infants and young children. Data from these studies have demonstrated that, for the pneumococcal serotypes common to both vaccines, the immunogenicity of PCV13 is comparable to that of Prevenar using a pre-determined set of immunological criteria. In addition, PCV13 elicits antibacterial functional antibodies to the six additional serotypes.
The company expects to complete its US filing for pediatric use of the vaccine in the first quarter of 2009, while initiating other pediatric filings in the near term. PCV13 is also being studied in global Phase III clinical trials in adults, with regulatory filings expected in 2010.
Emilio Emini, executive vice president of vaccine R&D at Wyeth Pharmaceuticals, said: Today’s submission is an important milestone for Wyeth and underscores the company’s commitment to help protect current and future generations from serious pneumococcal disease.