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FDA Panel Endorses Cervical Cancer Vaccine
 
 
  May 18, 5:58 PM EDT
By ANDREW BRIDGES
Associated Press Writer
 
Link to FDA briefing documents for the hearing:
http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222b-index.htm
 
WASHINGTON (AP) -- A vaccine with the potential to slash worldwide deaths from cervical cancer, the No. 2 cancer killer in women, should be approved for sales in the United States, a federal panel said Thursday.
 
A Food and Drug Administration advisory committee voted 13-0 to endorse the safety and effectiveness of Merck and Co.'s Gardasil, which blocks viruses that cause cervical cancer. The company said the vaccine could cut worldwide deaths from the disease by two-thirds.
 
However, the anticipated cost of the vaccine, administered in three shots over six months, is $300 to $500 - a possible impediment to widespread vaccination campaigns.
 
The drug protects against the two types of human papillomavirus (HPV) believed responsible for about 70 percent of cervical cancer cases. It also protects against two other virus types that cause 90 percent of genital wart cases. All four virus types are sexually transmitted.
 
The FDA is not required to follow the recommendations of its outside panels of experts, but usually does. An agency decision is expected by June 8.
 
HPV is the most common sexually transmitted disease. It affects more than 50 percent of sexually active adults. The cervical cancer it can cause kills about 290,000 women worldwide each year, including 3,500 in the United States where regular pap smears often detect precancerous lesions and early cancer.
 
"This is certainly a wonderful, good step in addition to our screening processes" in helping eradicate cervical cancer, said Dr. Monica Farley, who heads the advisory panel. She is a bacterial infectious disease expert at the Emory University School of Medicine in Atlanta.
 
Early opposition to Gardasil was based on concerns it could encourage sexual activity in preteens and teens. But that largely faded away because of the vaccine's potential for reducing cancer.
 
Making their case for approval, Merck officials suggested that Gardasil could be the biggest advance in preventing cervical cancer since the pap test.
 
"Gardasil has the potential to meet an unmet medical need as the first vaccine to prevent cervical cancer," Merck's Dr. Patrick Brill-Edwards told the Vaccine and Related Biological Products advisory committee.
 
Several speakers said the vaccine should not replace screening. Merck said the vaccine was not intended to do that but that it could eliminate many of the abnormalities the tests turn up.
 
"We would like to see the FDA mandate some sort of labeling or other mechanism to communicate to health care providers and patients the continued need for regular cervical screening," said Amy Allina, program director of the National Women's Health Network.
 
Merck said the vaccine could be used in females age 9 to 26, but would work best when given to girls before they begin having sex.
 
The company is seeking to license Gardasil in more than 50 countries, said Dr. Eliav Barr, who headed the vaccine program at Merck.
 
Pending action by the FDA, the national Advisory Committee on Immunization Practices will decide in June whether to endorse routine vaccination with the vaccine.
 
The committee's HPV vaccine group is recommending giving the vaccine to girls 11 and 12. The 15-member committee of experts who advise the government will consider recommendations for females 13 to 26. Merck seeks use of the vaccine in girls as young as 9. Dr. Nancy Miller, an FDA reviewer, cautioned that Gardasil does not necessarily protect against one or more of the four viruses in people already infected before they get the vaccine, and can increase their risk for precursors to cervical cancer.
 
Also, the drug does not protect against infection from the many other virus strains not included in the vaccine. In addition, FDA staff highlighted in briefing documents five cases where children with birth defects were born to women who received the vaccine around the time of conception. Merck said it was "highly unlikely" they were related to Gardasil.
 
Merck, based in Whitehouse Station, N.J., developed the vaccine and tested it in more than 27,000 females and males.
 
Thursday's discussion focused on its use in preventing HPV-related disease in girls and women, including those as young as 9. But only 250 9-year-old girls and boys received Gardasil in trials.
 
The anticipated cost of the vaccine, administered in three shots over six months, is $300 to $500. That could pose a barrier to widespread vaccination campaigns.
 
"The vaccine community will see this as an opportunity to prevent cancer. They will also see issues of availability and cost," said Dr. Bruce Gellin, a committee member and head of the federal vaccine policy office.
 
Analysts believe Gardasil sales could top $1 billion a year for Merck, which is battling thousands of lawsuits over its withdrawn painkiller Vioxx.
 
US advisers back Merck cervical cancer vaccine
 
Thu May 18, 2006 4:08 PM ET
By Lisa Richwine
 
GAITHERSBURG, Md., May 18 (Reuters) - A Merck & Co. Inc. (MRK.N: Quote, Profile, Research) vaccine to block 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 9.
 
The vaccine, Gardasil, could offer a major boost to women's health and the struggling drugmaker's fortunes. Some analysts predict annual sales topping $2 billion.
 
Shares of Merck rose after the panel vote, closing up 2.3 percent to $35.13 on the New York Stock Exchange.
 
Gardasil targets common types of the sexually transmitted human papilloma virus, or HPV, which causes genital and skin warts and most cervical cancer.
 
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 Dr. Monica Farley, the panel's chairwoman.
 
Gardasil is a key product for Merck, as it faces thousands of lawsuits alleging harm from withdrawn arthritis drug Vioxx and upcoming generic competition to its cholesterol drug Zocor.
 
A final FDA decision is expected by June 8, putting Merck ahead of a potential rival vaccine by GlaxoSmithKline Plc (GSK.N: Quote, Profile, Research)(GSK.L: Quote, Profile, Research).
 
Merck and France's Sanofi-Aventis (SASY.PA: Quote, Profile, Research) (SNY.N: Quote, Profile, Research) would market Gardasil through a joint venture in Europe if it won clearance there. Merck licensed the vaccine technology from Australian company CSL Ltd. (CSL.AX: Quote, Profile, Research).
 
 
 
 
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