Wyeth Pharmaceuticals, a division of Wyeth, announced that the US Food and Drug Administration (FDA) granted priority review to the company's Biologic License Application (BLA) for Prevnar 13, Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein), which was submitted on March 31. Priority review designation is given to products that, if approved, would be a significant therapeutic or public health advance. Based on this designation, Wyeth expects a regulatory decision within six months.
Wyeth is seeking an indication in the US for Prevnar 13 for the prevention of invasive pneumococcal disease (IPD) and otitis media caused by the 13 serotypes included in the investigational vaccine in children aged two months through five years. Seven of these serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) are included in Prevnar, Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) - the current global standard in PD prevention in infants and young children. The six additional serotypes (1, 3, 5, 6A, 7F and 19A) are associated with the greatest remaining burden of invasive disease. Both Prevnar 13 and Prevnar use CRM197 - an immunological carrier protein with a 20-year history of use in pediatric vaccines.
"Since its launch in 2000, our 7-valent pneumococcal vaccine, Prevnar, has significantly reduced the incidence of pneumococcal disease among infants and young children in the United States. Recently, however, disease due to pneumococcal serotypes not found in Prevnar, particularly serotype 19A, have increased in prevalence in many regions of the world, and are a significant public health concern," says Emilio Emini, executive vice president, Vaccine Research and Development, Wyeth Pharma. "Prevnar 13, which builds on the scientific foundation of Prevnar, is designed to provide protection against the 13 most prevalent serotypes associated with pneumococcal disease."
The Prevnar 13 submission to the FDA includes data from 13 phase-3 studies, involving more than 7,000 infants and young children.
The company initiated its global paediatric filings in late 2008 and, to date, has submitted regulatory applications for the 13-valent candidate vaccine in more than 40 countries worldwide. Prevnar 13 also is being studied in global phase-3 clinical trials in adults, with regulatory submissions expected in 2010.