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GlaxoSmithKline, the second biggest pharmaceutical company
in the world, announced on Monday that it does not expect U.S. approval for
its cervical cancer vaccine, Cervarix, until late 2009.
The news is the best ever for Merck & Co Inc., the
manufacturer of rival blockbuster vaccine Gardasil, which stock jumped 3
percent, Reuters reports.
In a statement released Monday, Glaxo said it had answered all the questions
raised by the Food and Drug Administration regarding its vaccine.
Moreover, the company decided that it will add results from a further phase
III study called HPV-008 to its original application. The clinical trial is
expected to end by the end of this year. “The final results will strengthen the
U.S.
label for Cervarix,” Barbara Howe, Glaxo's head of North American vaccine development,
said.
Since FDA usually takes six month to approve such a vaccine,
the U.S.
release of the products is expected by the middle of 2009.
Cervarix, like its rival Gardasil, is a vaccine that can be
administered to young women and is targeted against four strains of the human
papilloma virus. . According to medical studies, the virus accounts for about
70 percent of the cervical cancer cases and about 80 percent of the women
become infected with it throughout their lives.
Cervical
cancer is the second most common cause of cancer death in women worldwide,
resulting in nearly a half-million diagnoses and 280,000 deaths each year. In
2007, there were an estimated 11,000 new cases of cervical cancer and 3,600
deaths in the US.
Meanwhile, the FDA denied Merck’s request to market Gardasil
to women age 27 to 45 due to certain “issues” that preclude approval within the
expected review time frame, the agency said last week, although not specifying
what were the exact “issues” standing in the way of approval.
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