No Fast Track Review For Cervarix
LONDON - GlaxoSmithKline PLC revealed Thursday that the U.S. Food and Drug Administration has declined to grant a priority review to its experimental cancer vaccine Cervarix, adding to pressure on the drug maker after controversy surrounding its diabetes drug Avandia.
The FDA ruling means that Cervarix will have to go through a standard 10-month review, instead of a fast-track process that would have accelerated the approval and marketing of the vaccine in the key U.S. market.
Glaxo now expects to get the drug, which targets cervical cancer and is expected to become a multibillion-dollar product, to market in the United States sometime in 2008.
The company applied for U.S. marketing approval in March, hoping to receive a "priority review," which the FDA grants to medicines that represent a significant improvement compared with existing therapies.
Glaxo expects to launch the vaccine in Europe and several other markets in the second half of 2007. It was approved by health regulators in Australia earlier this month.
Gardasil, the vaccine that's already FDA approved, is designed to protect against HPV 6, 11, 16 and 18, while Cervarix is bivalent (HPV 16 and HPV 18).
Labels: Cervarix, HPV, HPV Vaccine
posted by ema @ 7:30 PM
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Is there any reason to choose Cervarix over Gardasil?
Gardasil also protects against two strains of HPV that cause genital warts. Cervarix only protects against the two strains of cervical cancer-causing HPV that Gardasil also protects against. It's unclear whether there are specific protective benefits of Cervarix compared to Gardasil.
According to the New Scientist there are two reasons for including the warts strains. The official one is that they can confuse screening tests, and the unofficial one is that it may make the vaccine more acceptable in cultures "where trying to prevent sexually transmitted infections is equated with promiscuity". If men are vaccinated to prevent disfiguring warts, they cannot pass on the cancer causing strains to women.
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