FDA Approves Merck’s Cervical Cancer Vaccine

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The New York Sun

Merck & Company won American approval to sell the first vaccine specifically designed to prevent a cancer, targeting the no. 2 malignancy of women worldwide.

The vaccine, called Gardasil, is intended to thwart cervical cancer by blocking infection from human papillomavirus, which is spread through sexual contact. The Food and Drug Administration yesterday permitted Gardasil for females ages 9 through 26, with the goal of inoculating girls before they may become sexually active.

About half a million women are diagnosed with cervical cancer each year. The approval raises the possibility that a cancer may be eliminated within a generation, specialists said. It is also a victory for Merck, the fourth-biggest American drugmaker, which has focused increasingly on vaccines and may generate $3 billion in annual sales from Gardasil alone.

“It’s important from a public health perspective because you’re eliminating a cancer,” an analyst in New York for Miller Tabak & Company, Les Funtleyder, said in a telephone interview. “The subtle point is these guys are creating new drugs for important health problems, which is what pharma is supposed to do.”

Shares of Merck, based in Whitehouse Station, New Jersey, rose 1 cent to $33.97 at 4:02 p.m. in New York Stock Exchange composite trading.

Gardasil shots will be given in three doses over six months, with each dose costing $120, Merck said. Affordability may help determine whether how effective the drug in quelling cervical cancer, since 80 percent of the cases are in poorer countries.

“Critical to success will be ensuring that women in the world’s poorest countries – where cervical cancer hits hardest – have rapid and affordable access to this life-saving new tool,” said Gabriel N. Hortobagyi, a physician at the University of Texas M.D. Anderson Cancer Center in Houston, and president of the American Society of Clinical Oncology, in a statement yesterday.

Human papillomavirus, or HPV, is one of the most common sexually transmitted viruses in the world, and causes genital warts as well as cancer. About 20 million people in America are infected, according to the U.S. Centers for Disease Control and Prevention.


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