DOW JONES NEWSWIRES
The Food and Drug Administration has extended the deadline for
its review of Wyeth's (WYE) advanced vaccine for pneumococcal
meningitis by three months to the end of the year.
The move came after the company, at the agency's request,
submitted additional data and specification information in late
July related to the product's makeup.
Wyeth spokesman Michael Lampe said the FDA needed more time to
review data that "demonstrates that production will be consistent
over time." The FDA hasn't asked for an additional clinical trial.
Prevnar 13 also is under regulatory review in Europe, and has been
approved for sale in Chile.
Wyeth is about to be acquired by Pfizer Inc. (PFE) in a
stock-and-cash deal currently valued at $66 billion, in part
because of its vaccine busines.
Wyeth's Prevnar vaccine has dealt a stunning blow to childhood
meningitis and related infections in the U.S. since it was
introduced in 2000, but a knockout punch has been elusive. The
company hopes Prevnar 13 offers broader protection against the
bacteria that causes the diseases and that its use might eventually
be expanded to include older adults.
-By Kevin Kingsbury, Dow Jones Newswires; 212-416-2354;
kevin.kingsbury@dowjones.com
(Peter Loftus contributed to this story)