The FDA extended approval of Pfizer's Prevnar 13 (pneumococcal 13-valent conjugate vaccine) for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae in people aged 50 or older. Karen Midthun, director of FDA's Center for Biologics Evaluation and Research, said the "approval provides an additional vaccine for preventing pneumococcal pneumonia and invasive disease in this age group."
The expanded indication came under the agency's accelerated approval pathway. In November, an FDA panel voted that clinical data supported expanding the use of the vaccine in older adults. The agency said results from randomised trials involving people aged 50 or older who received Prevnar 13 or Merck & Co.'s Pneumovax 23 (pneumococcal vaccine polyvalent) demonstrated that for the 12 common serotypes, Prevnar 13 induced antibody levels that were either comparable to or higher than the levels induced by Pneumovax 23.
The FDA noted that Prevnar 13 was evaluated in approximately 6000 people ages 50 and older, some of which had previously been administered Merck’s vaccine. An additional trial involving 85000 people aged 65 and up with no previous history of receiving Pneumovax 23 is being conducted to confirm the clinical benefit of Prevnar 13 in the prevention of pneumococcal pneumonia, the regulator added. Results from that trial are expected in 2013.
Pfizer recorded $2.8 billion in sales of Prevnar 13 for the nine months ended September 30. Credit Suisse analyst Catherine Arnold predicted the vaccine could generate $5.9 billion in sales by 2015, with the adult indication contributing approximately $1.8 billion.
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