FDA postpones new Prevnar ruling to January 2012

FDA has issued a 90-day extension of the action date for Pfizer’s Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM₁₉₇ Protein]) in adults 50 years of age and older. The extension results from the submission of additional data that Pfizer elected to present from 2 studies that were part of the original supplemental Biologics License Application.

These data, which are derived from an additional immune response assay method, were submitted to support FDA in its evaluation of the concomitant use of Prevnar 13 and trivalent inactivated influenza vaccine (TIV), Pfizer announced. FDA considered this data submission to be a major amendment to the filing.

Prevnar 13 is the world’s top-selling vaccine. In 2010 it brought Pfizer $3.7 billion in worldwide revenue. An expanded marketing approval would give sales a boost, reported the Associated Press.

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.

“FDA will be using the time to consider the additional data submitted by Pfizer that supports the use of the vaccine in adults aged 50 and older,” Bill Mader, RPh, told Drug Topics. Mader is lead consultant at Pharmacy Outcomes Specialists, in Lake Zurich, Ill. “Anytime drug companies submit additional data, either at the request of FDA or to support expanded uses for a drug product, the FDA is going to take the time to review the data. Not knowing all the background and what additional data was submitted, I’d say 3 months is not a long time for review.”

In a company press release, Pfizer’s Emilio Emini, PhD, chief scientific officer, vaccine research, said, “We are working closely with the FDA on its review. We remain confident that our application supports the approval of Prevnar 13 in adults aged 50 and older.”

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

Pfizer’s application to FDA is based on 6 phase 3 studies involving approximately 6,000 subjects. To date, the company has submitted regulatory applications for use of Prevnar 13 in adults 50 years of age and older in more than 40 countries. Earlier this year, Prevenar 13 was approved in Colombia, the Philippines, and Thailand for use in adults 50 years of age and older.