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news.The European Medicines Agency (EMA) has accepted Pfizer’s application seeking to expand the indication for Prevenar 13 in adults to include the prevention of pneumonia caused by the 13 pneumococcal serotypes contained in the vaccine.
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Streptococcus pneumonia (pneumococcus) is a gram-positive, alpha-hemolytic, aerotolerant, aerobic member of the genus Streptococcus.
Currently, Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) is approved for adults in Europe for the prevention of invasive pneumococcal disease.
Pfizer’s application is based on the positive results data from the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA), which showed 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.
Pfizer senior vice-president of Vaccine Research and Development Emilio Emini said pneumococcal pneumonia continues to be a serious health problem, causing significant illness and mortality in older adults.
"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," Emini said.
Recently, the company submitted a supplemental Biologics License Application (sBLA) to the US 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 the SBLA for review by the FDA’s Center for Biologics Evaluation and Research (CBER) is expected by the end of September 2014.
Later in 2014, the company intends to submit applications in other major markets, including Australia, Canada and Japan.
Image: Pfizer world headquarters. Photo: courtesy of Jim.henderson.