Wyeth Pharmaceuticals announced that it submitted a Biologic License Application (BLA) to the U.S. Food and Drug Administration for Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM(197) 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. Wyeth said 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 CRM(197) 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 CRM(197) – an immunological carrier protein with a 20-year history of use in pediatric vaccines, Wyeth said.

Wyeth noted that the Prevnar 13 submission to the FDA includes data from 13 Phase 3 studies, involving more than 7,000 infants and young children, and that it has initiated its global pediatric 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.

Pneumococcal disease “is complex and describes a group of illnesses, all of which are caused by the bacterium Streptococcus pneumoniae. PD affects both children and adults and includes invasive infections such as bacteremia/sepsis and meningitis, as well as pneumonia and otitis media (middle ear infection).”

(PRNewswire-FirstCall, 31 March 2009)