Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Wyeth Pharmaceuticals, a division of Wyeth, has announced that the FDA has granted fast track designation to the company's investigational 13-valent pneumococcal conjugate vaccine for infants and toddlers.
Subscribe to our email newsletter
Wyeth is seeking a pediatric indication for active immunization against invasive pneumococcal disease 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.
The company expects to complete its US filing for pediatric use of the vaccine in the first quarter of 2009. Wyeth 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 III global clinical trials in both infants and adults.