European Medicines Agency accepts application seeking new indication for Prevenar 13®1 for prevention of pneumococcal pneumonia in adults

Pfizer Inc. (NYSE:PFE) announced today that the European Medicines Agency (EMA) has accepted Pfizer’s application seeking to expand the indication for Prevenar 13* (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) in adults to include the prevention of pneumonia caused by the 13 pneumococcal serotypes contained in the vaccine.

“Pneumococcal pneumonia continues to be a serious health problem, causing significant illness and mortality in older adults,” said Dr. Emilio A. Emini, senior vice president, Vaccine Research and Development, Pfizer. “The results of the Community-Acquired Pneumonia Trial in Adults study underscore the potential benefits of Prevenar 13 in preventing disease in this age group.”

This application is based on the positive results of the landmark Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA), which demonstrated statistically significant reductions in vaccine-type pneumococcal community-acquired pneumonia (CAP), including non-invasive/non-bacteremic CAP, and invasive pneumococcal disease (IPD) in adults aged 65 and older. Prevenar 13 is currently approved for adults in Europe for the prevention of invasive pneumococcal disease.

Pfizer also recently submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration (FDA) seeking to add efficacy data regarding the use of Prevnar 13 in older adults to the prescribing information and to meet its commitment under FDA’s accelerated approval program. A decision regarding acceptance of this supplement for review by the FDA’s Center for Biologics Evaluation and Research (CBER) is expected by the end of September 2014. Pfizer plans to submit applications in other major markets, including Australia, Canada and Japan, later this year.