FDA issues 90-day extension for Pfizer's Prevnar 13 sBLA to treat pneumonia in adults

Pfizer Inc (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has issued a 90-day extension to the action date for the Company's supplemental Biologics License Application (sBLA) for use of Prevnar 13^®, (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM₁₉₇ Protein]) in adults aged 50 and older. This extends the review period to January 2012. The extension is due to additional data that Pfizer elected to submit from two studies that were part of the original sBLA. These data, which are derived from an additional immune response assay method, were submitted to support the FDA in its evaluation of the concomitant use of Prevnar 13 and trivalent inactivated influenza vaccine (TIV). The FDA considered this data submission to be a major amendment to the filing.

Prevnar 13 is under review for active immunization of adults 50 years of age and older for the prevention of pneumococcal disease (including pneumonia and invasive disease) caused by the 13 Streptococcus pneumoniae (S. pneumoniae) serotypes in the vaccine.

"We are working closely with the FDA on its review," says Emilio Emini, PhD, chief scientific officer, Vaccine Research, Pfizer. "We remain confident that our application supports the approval of Prevnar 13 in adults aged 50 and older."

Prevnar 13 was approved for use in infants and young children in Europe in December 2009 and in the U.S. in February 2010. It is currently approved for that use in more than 100 countries.

Pfizer's application to the FDA is based on six Phase 3 studies involving approximately 6,000 subjects. To date, the Company has submitted regulatory applications for use of Prevnar 13 in adults aged 50 and older in more than 40 countries. Earlier this year, Prevenar 13, as it is known in most countries outside the U.S., was approved in Colombia, the Philippines and Thailand for use in adults aged 50 and older.