HPV Virus Cervarix Works Well in Trial, Drug Maker Says

Cervarix, the GlaxoSmithKline vaccine for the human papillomavirus (HPV), performed well in a large clinical trial against not only the two types of HPV most associated with cervical cancer, but also other strains of the disease, company officials said.

Cervarix competes with Gardasil, the vaccine given to millions of girls and young women in the United States and around the world to protect against cervical cancer. Gardasil, the blockbuster shot made by Merck & Co. and approved in the U.S. in 2006, has been met with some controversy and concerns about deadly allergic reactions and severe complications in some patients.

Recently, the Food and Drug Administration ordered Merck to beef up the warning label on Gardasil to further caution physicians and users of some of the risks associated with the vaccinations.

Study Shows Benefits of Cervarix

In the recent company-sponsored study of Cervarix, 18,644 girls and women between the ages of 15 and 25 were given the vaccine and tested to see how the drug prevented lesions caused by HPV types 16 and 18, which are the most likely strains of the virus to cause cervical cancer. Women in the study either had evidence of previous or current HPV infection or no such evidence of infections.

Researchers found that women who received all three doses of Cervarix were provided with 92.9 percent protection from lesions. Further, there was evidence that the vaccine protected the women against lesions caused by HPV types 31, 33, and 45, which are the next most likely to cause cervical cancer after strains 16 and 18, according to GlaxoSmithKline.

The study was the largest-to-date to test Cervarix in preventing HPV and cervical cancer.

Seeking U.S. Approvals

Cervarix is not yet approved for use in the United States, but it is available in some European nations and other countries around the world. If granted FDA approvals, the vaccine would directly compete with Merck’s Gardasil and according to the study results, may protect against more strains of HPV which may cause cervical cancer.

In 2008, Cervarix generated $231 million in sales around the globe. A decision on whether the U.S. FDA will grant the new vaccine approvals could be made later this year.