EMA accepts expanded indication for Prevenar 13 for Pneumonia - Pfizer

Pfizer has announced 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. 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 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.