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.
"We are pleased to be another step closer to potentially bringing Prevnar 13 to adults aged 50 and older," says Emilio Emini, PhD, chief scientific officer, Vaccine Research, Pfizer. "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."
Prevnar 13, which is based on the scientific foundation of Prevnar®** (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), was approved for use in infants and young children in Europe in December 2009 and in the United States in February 2010. Like Prevnar, Prevnar 13 uses conjugate technology that has been shown to confer a high antibody response in infants and toddlers.
In the United States, Pfizer is seeking approval from the FDA to market Prevnar 13 for the active immunization of adults 50 years of age and older for the prevention of pneumococcal disease (including pneumonia and invasive disease) caused by the Streptococcus pneumoniae (S. pneumoniae) serotypes in the vaccine. In the European Union, the Company is seeking marketing authorization for active immunization for the prevention of disease caused by S. pneumoniae in adults aged 50 years and older. Pfizer plans regulatory submissions in additional countries in 2011.
Pfizer's applications to the FDA and EMA are based on six Phase III studies involving approximately 6,000 subjects. Data from the studies are expected to be shared in peer-reviewed forums beginning in 2011.
Pneumococcal disease is a group of illnesses caused by the bacterium S. pneumoniae, also known as pneumococcus. It includes invasive infections such as bacteremia, sepsis, and meningitis, as well as non-invasive infections, such as pneumonia and otitis media. Pneumococcal disease is a major cause of illness and death in adults worldwide.
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* Prevnar 13 is referred to as Prevenar 13*** in most countries outside the United States.
**Prevnar is referred to as Prevenar*** in most countries outside the United States.