Wyeth Pharmaceuticals, a division of Wyeth, has submitted a Biologic License Application (BLA) to the US Food and Drug Administration (FDA) for Prevnar 13, Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein). Last year, the FDA granted Prevnar 13 Fast Track designation, which is designed to facilitate review of products that address serious or potentially life-threatening conditions for which there is an unmet medical need.
Prevnar 13 is designed to protect against the 13 most prevalent serotypes associated with pneumococcal disease (PD), the leading cause of vaccine-preventable death worldwide. 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 paediatric vaccines.
"We are pleased that, with this milestone, we are now one step closer to bringing Prevnar 13 to infants and children," says Emilio Emini, executive vice president, Vaccine Research and Development, Wyeth Pharmaceuticals. "Prevnar, our currently available vaccine, has both proven clinical efficacy and documented effectiveness, which has resulted in a significant public health impact. Prevnar 13 builds on the scientific foundation of Prevnar and, if approved, will provide coverage for the 13 most prevalent pneumococcal serotypes associated with pneumococcal disease, including serotype 19A, which has emerged as a serious public health threat in the United States and around the world."
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 is also being studied in global phase-3 clinical trials in adults, with regulatory submissions expected in 2010.