HPV Vaccines Submitted for FDA Approval in 2006

Cervarix, the brand-name human papillomavirus (HPV) vaccine from GlaxoSmithKline, will be submitted for Food and Drug Administration (FDA) approval this year, bringing women closer to effectively preventing the cause of most cervical cancer. The drug will also be submitted for approval in Europe next month. In clinical trials, Cervarix has been 100 percent effective in preventing two strains of HPV which cause 70 percent of cervical cancer.

On Wednesday, a spokesperson for the company said that the FDA may allow this application to have a rapid review, speeding up the approval process. The FDA has already approved rapid review for Merck’s brand-name HPV vaccine, Gardasil, and intends to make a decision on it by June 8, 2006. Gardasil produced nearly identically effective results in preventing cancer causing HPV.

LEARN MORE about HPV vaccines from Ms. Magazine.

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Independent 2/9/06; In-PharmaTechnologist 2/10/06; Kaiser 2/9/06, 2/13/06;

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