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news.Pfizer has filed supplemental applications to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to expand the use of Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) to adults 50 years of age and older for the prevention of pneumococcal disease caused by the 13 serotypes contained in the vaccine.
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Prevnar 13, which is based on the scientific foundation of Prevnar, was approved for use in infants and young children in Europe in December 2009 and in the US in February 2010.
The FDA is targeting a review cycle of 10 months from the application’s submission date, resulting in an expected action date in October 2011, subject to the FDA’s acceptance of the application. The EMA will follow the centralized procedure for review of Pfizer’s application.
Pfizer’s applications to the FDA and EMA are based on six Phase III studies involving approximately 6,000 subjects.
Pfizer Vaccine Research chief scientific officer Emilio Emini said they are pleased to be another step closer to potentially bringing Prevnar 13 to adults aged 50 and older.
"These milestones are further examples of the company’s commitment to help prevent pneumococcal disease through vaccination and to improve health and well-being at every stage of life," Emini said.