-FDA extends review time by 90 days-
COLLEGEVILLE, Pa., Aug. 11 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced it received notice that the action date for the U.S. Food and Drug Administration's (FDA) review of the Biologics License Application (BLA) for Prevnar 13(TM), (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) has been extended from September 30, 2009, to December 30, 2009. In response to an FDA request, Wyeth submitted additional analytical method validation and specification information relating to physical/chemical properties of the product in late July. FDA considered this to be a major amendment and, as a result, they have elected to extend the review cycle for Prevnar 13 by 90 days. Prevnar 13 is under review for active immunization of infants and young children for the prevention of invasive disease and otitis media caused by 13 Streptococcus pneumoniae (S. pneumoniae) serotypes.
"This is a significant application that is under priority review and we are working closely with the FDA on the review, including conduct of the pre-approval inspections," says Emilio Emini, Ph.D., executive vice president, Vaccine Research and Development, Wyeth Pharmaceuticals. "Priority review designation is given to products that, if approved, would be a significant therapeutic or public health advance. We continue to believe that our application supports the approval of Prevnar 13."
Prevnar 13(TM) is based on the scientific foundation of Prevnar(R) (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), the standard in pneumococcal disease prevention for infants and young children. It contains the seven serotypes in Prevnar (4, 6B, 9V, 14, 18C, 19F and 23F), plus six additional serotypes (1, 3, 5, 6A, 7F and 19A) responsible for the greatest remaining burden of invasive disease. Prevnar has been available in the U.S. for more than nine years. It is currently available in 95 countries and more than 235 million doses have been distributed worldwide.
The Prevnar 13 submission is based on a clinical trial program of 13 core Phase 3 studies involving more than 7,000 infants and young children. To date, the company has submitted regulatory applications for Prevnar 13 in more than 50 countries spanning six continents, with filings in additional countries planned. In July, Prevenar 13*, as it is known outside the U.S., was approved in Chile for use in infants and young children.
About Pneumococcal Disease
Pneumococcal disease is complex and describes a group of illnesses all caused by the bacterium Streptococcus pneumoniae. Pneumococcal disease is the leading cause of vaccine-preventable death worldwide in children younger than 5 years of age and is estimated to cause up to one million deaths worldwide in children each year.
Pneumococcal disease affects both children and adults, and includes invasive infections such as bacteremia/sepsis and meningitis, as well as pneumonia and otitis media.
