The FDA has extended the action date for its review of Prevnar 13’s BLA from September 30, 2009, to December 30, 2009. In response to an FDA request, Wyeth submitted additional analytical method validation and specification information relating to physical/chemical properties of the product in late July. According to Wyeth, the FDA considered this to be a major amendment and, as a result, has elected to extend the review cycle for the vaccine by 90 days. Prevnar 13 is under review for active immunization of infants and young children for the prevention of invasive disease and otitis media caused by 13 Streptococcus pneumoniae (S. pneumoniae) serotypes.

“This is a significant application that is under priority review and we are working closely with the FDA on the review, including conduct of the pre-approval inspections,” said Emilio Emini, Ph.D., executive vice president, Vaccine R&D, at Wyeth.

Prevnar 13 is based on the scientific foundation of Prevnar (Pneumococcal 7-valent Conjugate Vaccine), the standard in pneumococcal disease prevention for infants and young children. It contains the seven serotypes in Prevnar, as well as six additional serotypes responsible for the greatest remaining burden of invasive disease. Prevnar has been available in the U.S. for more than nine years. It is currently available in 95 countries and more than 235 million doses have been distributed worldwide.

The Prevnar 13 submission is based on a clinical trial program of 13 core Phase III studies involving more than 7,000 infants and young children. To date, the company has submitted regulatory applications for Prevnar 13 in more than 50 countries spanning six continents, with filings in additional countries planned. In July, Prevenar 13*, as it is known outside the U.S., was approved in Chile for use in infants and young children.

Read Wyeth’s profile in this year’s Top Companies report!