A Merck vaccine
that blocks a sexually transmitted virus that causes
cervical cancer moved closer to the market on Thursday as
U.S. advisers unanimously said it was safe and
effective for women and girls as young as age 9.
Gardasil, could offer a major boost to women's health and
the struggling drugmaker's fortunes. Some analysts predict
annual sales topping $2 billion.
common types of the sexually transmitted human
papillomavirus, or HPV, which causes genital warts and skin
warts and most cervical cancer cases. Cervical cancer
is an AIDS-defining condition among HIV-positive
Members of a Food
and Drug Administration advisory panel said they were
persuaded by Merck's data showing Gardasil prevented
early-stage cervical cancer and precancerous lesions.
Several cautioned, however, that the vaccine worked
only against four HPV types and that women would still
need regular screening for the disease.
"It's not going
to get rid of all cervical cancer. There are other HPV
types that cause cancer," said Monica Farley, the panel's
A final FDA
decision is expected by June 8, putting Merck ahead of a
potential rival vaccine in development by GlaxoSmithKline.
France's Sanofi-Aventis would market Gardasil through a
joint venture in Europe, if the drug wins
clearance there. (Reuters)
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