FDA Misses Action Date for Pfizer’s Prevnar 13

The FDA has not yet completed its review of the BLA for Prevnar 13, Pfizer’s13-valent pneumococcal conjugate vaccine. The review had a prescription drug user fee (PDUFA) action date of December 30, 2009.

“We remain confident that the data in the BLA support the approval of Prevnar 13,” said Emilio Emini, Ph.D., chief scientific officer, Vaccine Research, Pfizer. “We will continue to work closely with the FDA to help expedite the completion of its review of our BLA.”

In May 2009, Prevnar 13 was designated for priority review, and in August 2009 the FDA extended its review by 90 days from the original action date of September 30, 2009, to December 30, 2009, based on additional manufacturing data requested by the FDA. Pfizer is seeking an indication for Prevnar 13 for active immunization of infants and toddlers for the prevention of invasive disease and otitis media caused by the 13 Streptococcus pneumoniae (S. pneumoniae) serotypes in the vaccine.

To date, Prevnar 13 has been approved for use in infants and young children in 34 countries. Further pediatric regulatory filings for Prevnar 13 are being reviewed in various countries. Prevnar 13 is also being studied in global Phase III trials in adults, with regulatory submissions expected in 2010.