U.S. OKs Glaxo's Cervical Cancer Shot

GlaxoSmithKline announced Friday that the Food and Drug Administration has approved its Cervarix vaccine for U.S. females ages 10 to 25.

Cervarix fights two strains of the STD human papillomavirus (HPV) linked to about 70 percent of cervical cancers. In company studies, it was 93 percent effective in preventing a pre-cancerous change associated with HPV. In addition, it was 89 percent effective in preventing pre-cancerous lesions from the third most-common cancer-causing HPV type.

Merck & Co.'s competing HPV vaccine, Gardasil, targets the same strains as Cervarix as well as two that cause genital warts. Gardasil was cleared by FDA in 2006. Also on Friday, the agency approved Gardasil for preventing genital warts in males ages nine through 26.

Cervarix contains a novel additive designed to boost the immune response. A Glaxo study showed Cervarix produced more antibodies than Gardasil, but the researchers did not study whether these higher levels provided more protection against cancer. Glaxo had sought FDA's approval of Cervarix since 2007, but the agency delayed its decision while it requested more data.

Gardasil costs roughly $360 for a three-shot series, while Glaxo has not yet announced a price for Cervarix. Some critics question whether it is cost-effective to vaccinate for cervical cancer in the United States, since the disease is often caught early through Pap smears and is largely treatable in its early stages. Still, around 4,000 U.S. women die of the disease annually. Concerns about immunizing boys for genital warts have also been raised, since the warts often clear on their own without treatment.

Cervarix will debut on the market later this year, said Glaxo. The vaccine got another boost on Friday when Japan -- the world's second-largest pharmaceutical market, after the United States -- approved it, making Cervarix the first cervical cancer vaccine available there.

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