GSK Awaits FDA Decision On Cervarix HPV Vaccine, Hopes To Compete With Merck's Gardasil

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 12 May 2009 - 5:00 PDT

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FDA is expected to make a decision in the next several months over whether to approve GlaxoSmithKline's human papillomavirus vaccine Cervarix for the U.S. market, the AP/Philadelphia Inquirer reports. If approved, Cervarix is expected to face a tough fight to take away market share from Merck's Gardasil, an HPV vaccine that has been available in the U.S. for three years, according to the AP/Inquirer. Although both vaccines target HPV strains 16 and 18, which cause about 70% of cervical cancers, Gardasil also has been shown to protect against most cases of genital warts. Experts say physicians will consider this fact in determining which vaccine to use for their patients.

In 2007, FDA rejected GSK's approval application for Cervarix, saying that it needed more data from a study of 18,000 women that was ongoing at the time. GSK submitted the final data to FDA in March and is awaiting the agency's decision. The results of the study and two other studies of Cervarix will be released this weekend at a conference in Sweden. Partial results of the two other studies, which were obtained by the Associated Press, show that Cervarix offers adequate protection against 12 additional types of HPV. Meanwhile, Merck also plans to release new research on Gardasil at the conference showing that the vaccine is capable of blocking HPV type 16 for at least nine-and-one-half years (Johnson, AP/Philadelphia Inquirer, 5/8).

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