FDA delays decision on Pfizer's Prevnar 13
The FDA will take 90 more days to review Pfizer's request that Prevnar 13 be approved for adults 50 and over. Pfizer has submitted additional data gathered from two studies of the vaccine used in conjunction with a trivalent inactivated influenza vaccine, and the agency needs more time to review the sBLA. A decision is now expected in January 2012.
"We are working closely with the FDA on its review," said Pfizer vaccine research chief Emilio Emini in a statement. "We remain confident that our application supports the approval of Prevnar 13 in adults aged 50 and older."
Prevnar 13, which Pfizer acquired through its merger with Wyeth, earned $3.7 billion in 2010--with more to come if the pharma giant can secure an expanded approval. Emini has previously stated that one of his company's primary goals for its newly acquired vaccine division is to target adult markets. The vaccine's indication has already been expanded to include infants and young children.
- here's Pfizer's release on the FDA decision
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