Wyeth Pharmaceuticals, a division of Wyeth, has submitted a biologic license application to the FDA for Prevnar 13, pneumococcal 13-valent conjugate vaccine.
The Prevnar 13 submission to the FDA includes data from 13 Phase III studies, involving more than 7,000 infants and young children. The company 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 designed to protect against the 13 most prevalent serotypes associated with pneumococcal disease, the leading cause of vaccine-preventable death worldwide.
Prevnar 13 is also being studied in global Phase III clinical trials in adults, with regulatory submissions expected in 2010.
Emilio Emini, executive vice president of vaccine R&D at Wyeth Pharmaceuticals, said: We are pleased that, with this milestone, we are now one step closer to bringing Prevnar 13 to infants and children. Prevnar 13 builds on the scientific foundation of Prevnar and, if approved, will provide coverage for the 13 most prevalent pneumococcal serotypes associated with pneumococcal disease, including serotype 19A, which has emerged as a serious public health threat in the US and around the world.