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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.
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.