2nd UPDATE: FDA OKs Glaxo's Cervarix; Expands Gardasil To Men
October 16 2009 - 2:54PM
Dow Jones News
The Food and Drug Administration approved GlaxoSmithKline PLC's
(GSK) Cervarix vaccine designed to protect against cervical cancer
in womenand expanded the approval of Merck & Co.'s (MRK)
competitor vaccine Gardasil for males to protect against genital
warts. Cervarix will compete against Gardasil, which was first
approved for use in girls and women in 2006. Cervarix was approved
for use in women ages 10 to 25 and Gardasil was approved for use in
males ages nine through 26.
FDA's approval of both vaccines follows a recommendation by an
outside panel of medical experts in September. Regarding Cervarix,
the panel said the vaccine was safe and effective at preventing an
infection that can cause cervical cancer in women as well as a
precancerous condition that can lead to cervical cancer. On
Gardasil, the panel also said the vaccine was safe and effective
for use in males, although some panel members said they weren't
sure how long the vaccine offers protection to those who receive
it.
Cervarix is designed to protect against cervical cancer and
other conditions linked to two strains of human papillomavirus, or
HPV, a common sexually transmitted disease. Cervarix protects
against HPV strains 16 and 18, which are linked to about 70% of
cervical cancer cases in the U.S. Gardasil also protects against
the same strains along with two others that are linked to genital
warts in both men and women. There's also evidence that Cervarix
protects against cancer caused by another HPV strain that is
closely related to types 16 and 18.
The FDA has said that about 40 strains of HPV infect the human
genital tract, and so neither Cervarix nor Gardasil protects
against all HPV infection.
Glaxo first sought FDA approval for Cervarix in 2007, but the
FDA said it needed more information before it would consider
approving the vaccine. Glaxo refiled the application for Cervarix
in March.
During last month's FDA advisory committee meeting, the agency
raised concerns about a higher rate of miscarriages among females
who received Cervarix and said it couldn't rule out a "small
effect" on pregnancies. (Cervarix and Gardasil are not approved for
use in pregnant women.)
The agency said it would require a post-marketing safety study
to monitor the outcome of pregnancies in women who might receive
Cervarix along with other potential safety concerns. The FDA is
also requiring Merck to conduct long-term safety studies of
Gardasil.
Gardasil generated $1.4 billion in sales for Merck last year,
although the sales pace has slowed so far this year amid lingering
questions about the vaccine's safety. Expanded approval of the
vaccine could boost sales.
In August, the FDA and Centers for Disease Control and
Prevention said the benefits of Gardasil outweighed its risks after
a new CDC-led safety review showed higher rates of fainting and
blood clots. In June, the FDA strengthened Gardasil's label to warn
doctors about fainting and recommended that vaccine recipients be
closely monitored for 15 minutes after receiving the vaccine.
HPV vaccines are designed to be administered before people
become sexually active. In the U.S. the CDC recommends that
Gardasil be offered to 11-to-12 year old girls along with other
vaccines that are routinely given to that age group. Once vaccines
are approved by the FDA, they are later considered by a CDC
advisory panel. Private insurance companies typically wait for CDC
panel endorsement of vaccines before agreeing to pay for themBoth
Cervarix and Gardasil are set for consideration by the CDC panel
next week.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com