FDA panel gives nod to Gardasil approval
Merck's cervical cancer vaccine is safe and effective, FDA committee says in non-binding 13-0 vote.
By Aaron Smith, CNNMoney.com staff writer

NEW YORK (CNNMoney.com) - An FDA advisory committee recommended for approval Merck's experimental cervical cancer vaccine Gardasil, said Merck and the agency.

The panel of advisors voted unanimously, 13-0, that Gardasil is safe and effective in girls and young women ages 9 to 26, according to the Food and Drug Administration and Merck (up $0.79 to $35.13, Research). The vote is not binding, but the FDA follows the advice of its panels most of the time.

"We are thrilled that the advisory committee reviewed our extensive clinical data, that we submitted from over 27,000 subjects, and made a unanimous approval for the vaccine," said Rick Haupt, executive director at Merck's vaccine division.

The FDA will make its final decision regarding Gardasil by June 8, and the vaccine could be on the market by late summer. The vaccine would be used to prevent human papillomavirus, a sexually-transmitted virus that causes most cases of cervical cancer. Haupt said the vaccine will also be reviewed by the Advisory Committee on Immunization Practices, partly to determine whether it will be covered by public funding for uninsured children.

Gardasil's blockbuster potential could help Merck fill some of its sales gap from the market withdrawal of Vioxx, an arthritis painkiller that used to total $2.5 billion in annual sales, and the impending patent expiration for the cholesterol-cutting Zocor, with $4.4 billion in annual sales.

Gardasil's annual sales could reach $2 billion, according to J.P. Morgan analyst Jami Rubin, while Barbara Ryan of Deutsche Bank North America has projected sales of $1.6 billion.

Gardasil is most effective, as a preventative, when used in children, years before they become sexually active. The FDA advisors voted that Gardasil is safe for use in girls as young as 13. Controversy regarding the delicate topic of teenage sexuality surrounded the vaccine last year, but religious groups recently spoke in support of Gardasil, acknowledging its life-saving potential.

The data from Gardasil's late-stage studies has been strong. The vaccine showed 100 percent efficacy in preventing HPV, which causes 70 percent of cervical cancer cases, according to Merck. This type of cancer kills nearly 4,000 women in the U.S. annually and nearly 300,000 worldwide, according to the National Cervical Cancer Coalition.

Gardasil has also shown 100 percent efficacy is preventing the sexually-transmitted viruses that cause 90 percent of vaginal and vulvar lesions in young women, including genital warts, according to Merck.


To read about Merck's first-quarter earnings, click hereTop of page

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