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FDA panel backs Glaxo cervical cancer vaccine
 
 
  Wed Sep 9, 2009 3:58pm EDT
 
By Lisa Richwine
 
GAITHERSBURG, Maryland (Reuters) - GlaxoSmithKline PLC's proposed cervical cancer vaccine is safe and effective for girls and young women ages 10 to 25, a U.S. advisory panel said on Wednesday.
 
The endorsement from Food and Drug Administration advisers moves the Cervarix vaccine closer to the U.S. market to compete with Merck & Co's Gardasil shot.
 
The panel will vote later Wednesday on whether Merck should be allowed to widen its potential market by promoting Gardasil for men and boys as young as 9 for prevention of genital warts.
 
Both vaccines are designed to protect against infection with the sexually transmitted human papillomavirus (HPV), which causes cervical cancer and genital warts.
 
FDA advisers, in an 11-1 vote, said Cervarix appeared safe. Some urged monitoring of miscarriages, which were reported at a higher rate around the time of vaccination compared with a hepatitis A shot. Others urged tracking of muscle and neurological problems seen in a small number of patients.
 
"The data we have seen to date are reassuring, said Dr. LisaRider, a panel member and official at the National Institutes of Health, adding "I think we do need very strong post-marketing studies" of autoimmune conditions that could cause neurological harm.
 
The committee voted 12-1 that Cervarix was effective.
 
The FDA usually follows panel recommendations. Glaxo said a final decision on Cervarix may come as early as this month.
 
The vaccine already is approved in 98 countries, but some analysts say it will be hard for Glaxo to compete against Gardasil's three-year headstart in the U.S. market. Gardasil won FDA clearance in 2006, while Cervarix stalled following Glaxo's initial application in 2007.
 
The delays mean Cervarix is no longer the mega blockbuster hope it once was, although FDA approval could still be a minor positive catalyst for Glaxo shares, Citigroup analysts said.
 
Four years ago, previous chief executive Jean-Pierre Garnier touted the vaccine as Glaxo's most important new product. But the British drugmaker missed the opportunity to vaccinate the initial group of eligible teenage girls in the United States, ceding that business to Gardasil.
 
Consensus forecasts ahead of the panel decision suggest Cervarix will generate worldwide sales of about $1.2 billion in 2013, equivalent to some 2.5 percent of expected Glaxo sales for that year, according to Thomson Reuters I/B/E/S.
 
Cervical cancer is often caught early in the United States through Pap smears while the disease is treatable. Still, about 4,000 U.S. women die each year from the disease. Worldwide deaths from the disease total about 280,000, mostly in developing countries where screening is lacking.
 
"If approved, Cervarix will help provide protection against cervical cancer, a devastating disease that is responsible for thousands of deaths in U.S. women each year," said Barbara Howe, director of Glaxo's North American vaccine development.
 
The company promised to track potential complications and miscarriages after approval. Neither Cervarix nor Gardasil is recommended for pregnant women.
 
Both vaccines fight two HPV strains that cause about 70 percent of cervical cancers. Gardasil also targets two other HPV strains that cause genital warts. It is unclear how long protection lasts or if booster shots will be needed.
 
HPV also can cause penile and anal cancers in males, although both are rare.
 
Glaxo shares rose 0.5 percent to $39.23 on the New York Stock Exchange, while Merck shares gained 1.8 percent to $31.53 on the NYSE.
 
(Reporting by Lisa Richwine and Ben Hirschler; Editing by Gary Hill)
 

FDA Panel Backs GlaxoSmithKline's Cervical-Cancer Vaccine
 
Wall St Jnl By JENNIFER CORBETT DOOREN
 
A Food and Drug Administration panel Wednesday backed GlaxoSmithKline PLC's Cervarix vaccine that is designed to protect against cervical cancer.
 
Specifically, the panel of outside medical experts voted that 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. The votes amount to a recommendation that the FDA approve the vaccine for use in females 10 to 25 years old.
 
The agency could make a decision by Sept. 29. Cervarix, one of Glaxo's most important new products, is currently approved in about 100 countries outside the U.S. If approved in the U.S., Cervarix would compete against Merck & Co.'s Gardasil, which was approved in 2006 and is also available overseas.
 
Later Wednesday, the same FDA panel will review Merck's application to expand Gardasil's use in males to prevent genital warts.
 
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.
 
Glaxo first sought FDA approval for Cervarix in 2007, but the FDA said it needed more information before it would consider approving the vaccine.
 
In a presentation to the panel, both the FDA and Glaxo officials said Cervarix was effective at preventing HPV infection from strains 16 and 18 as well as preventing a precancerous condition that can lead to cervical cancer. There's also evidence the vaccine protects against a few other HPV strains that are closely related to types 16 and 18, both the company and FDA said.
 
On the safety side, the FDA raised concerns about a higher rate of miscarriages among females who received Cervarix and couldn't rule out a "small effect" on pregnancies. (Cervarix and Gardasil aren't 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 including the development of autoimmune diseases like rheumatoid arthritis and multiple sclerosis. In its 2007 review of Cervarix, the FDA said that it was concerned about an "imbalance" of possible autoimmune disorders seen in clinical trials. However, the agency said an additional review of the data by its own staff and an outside rheumatologist concluded the differences weren't statistically significant.
 
Officials from Glaxo said they were planning a post-marketing study that would involve 100,000 women in the U.S., which would include a pregnancy registry. The company is also conducting another large post-marketing study in Finland.
 
Neither Cervarix nor Gardasil protects against all HPV infection.
 
HPV vaccines are designed to be administered before people become sexually active. In the U.S. the Centers for Disease Control and Prevention recommends that Gardasil be offered to 11-to-12 year old girls along with other vaccines that are routinely given to that age group.
 
If Cervarix is approved by the FDA, the vaccine later goes before a CDC advisory panel. Private insurance companies typically wait for CDC panel endorsement of vaccines before agreeing to pay for them.
 
 
 
 
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