The  US Food and Drug Administration (FDA) has granted Fast Track designation to Wyeth  Pharmaceuticals’ (Collegeville,   PA) investigational 13-valent  pneumococcal conjugate vaccine for infants and toddlers. Wyeth is seeking a  pediatric indication for active immunization against invasive pneumococcal  disease (IPD) and otitis media caused by serotypes included in the vaccine. The  vaccine includes six new serotypes (1, 3, 5, 6A, 7F, and 19A) in addition to  the seven serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) included in Prevnar,  pneumococcal 7-valent conjugate vaccine (diphtheria CRM197 protein), also known  as PCV7.

  Fast  Track designation is designed to facilitate review of products that address  serious or potentially life-threatening conditions for which there is an unmet  medical need. With Fast Track designation, Wyeth plans to submit the biologics  license application on a rolling basis as sections of the application are  completed, enabling the FDA to begin review sooner.

  Wyeth  expects to complete its US  filing for pediatric use of the vaccine in the first quarter of 2009. The  company is also exploring opportunities to accelerate the timing of pediatric  filings of the vaccine in the rest of the world from its current target of the  first quarter of 2009. Wyeth’s investigational 13-valent pneumococcal conjugate  vaccine is being studied in Phase 3 global clinical trials in both infants and  adults.

News

The US Food and Drug Administration (FDA) has granted Fast Track designation to Wyeth Pharmaceuticals’ (Collegeville, PA) investigational 13-valent pneumococcal conjugate vaccine for infants and toddlers.