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GSK's Cervarix finally wins US approval

Published on 19/10/09 at 01:31pm

US regulator the FDA has approved GlaxoSmithKline's cervical cancer vaccine Cervarix, finally allowing the company to bring it to the world's largest pharma market.

Clinical delays with the product allowed Merck's rival vaccine Gardasil to beat it to market, launching in the US and Europe in 2006, and Cervarix subsequently suffered a two-year US delay following FDA demands for more information about it.

Cervarix has fared better in Europe where it was approved in 2007 and picked by the UK government for its nationwide schoolgirl vaccination programme, which began last month.

The vaccine now has a US licence for the prevention of cervical pre-cancers and cervical cancer for use in girls and young women (aged 10-25).

It can be used against pre-cancers and cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18, which account for around 75% of cervical cancers in the US.

"The approval of Cervarix will bring an important new cervical cancer vaccine to girls and young women," said Deirdre Connelly, GSK's president of North American Pharmaceuticals.

"Immunisation with a vaccine such as Cervarix - along with annual doctor visits and Pap tests - will help protect women from cervical cancer, the second leading cause of cancer death in women in their twenties and thirties."

GSK expects to launch Cervarix in the US before the end of the year, when it will compete against Merck's Gardasil.

Rival vaccine Gardasil extends its licence

On the same day regulators approved Cervarix, Gardasil won an extension to its own licence, allowing it to be used in boys and men aged 9-26 for the prevention of genital warts caused by human papillomavirus (HPV) types 6 and 11.

HPV is the most common sexually transmitted infection in the United States and most genital warts are caused by HPV infection.

"This vaccine is the first preventive therapy against genital warts in boys and men ages 9 through 26, and, as a result, fewer men will need to undergo treatment for genital warts," said Karen Midthun, acting director of the FDA's Center for Biologics Evaluation and Research.

Each year, about 2 out of every 1,000 men in the United States are newly diagnosed with genital warts.

FDA approval is the first step in a two-step process, that will see advisors vote first on whether to recommend administration of Gardasil for use in males, and then on public funding through the US Centers for Disease Control and Prevention (CDC) contract.

The company said these votes are expected on 21 October.

Gardasil is already approved for use in girls and women ages 9-26 for the prevention of cervical, vulvar and vaginal cancer caused by HPV types 16 and 18; precancerous lesions caused by types 6, 11, 16, and 18; and genital warts caused by types 6 and 11.

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