Wyeth Pharmaceuticals, a division of Wyeth announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to the company's investigational 13-valent pneumococcal conjugate vaccine for infants and toddlers.

Wyeth is seeking a paediatric 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.

"While the incidence of pneumococcal disease has been substantially reduced since our introduction of Prevnar in the United States, pneumococcal disease remains a health threat to children, specifically as emerging strains, such as 19A, become more prevalent," says Emilio Emini, Ph.D., Executive Vice President, Vaccine Research and Development, Wyeth Pharmaceuticals. "With that in mind, we are very pleased that the FDA has granted Fast Track designation to our investigational 13-valent vaccine for paediatric use".

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 paediatric use of the vaccine in the first quarter of 2009. Wyeth is also exploring opportunities to accelerate the timing of paediatric 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.

Wyeth recently has achieved significant success in bringing new products to market. In the first quarter of 2008 alone, Wyeth obtained three new product approvals in the following therapeutic areas: major depressive disorder, Haemophilia A and opioid-induced constipation.