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FDA Close To Decision On Approval Of Cervical Cancer Drug

Added May 26th, 2006

The Food and Drugs Administration is said to be close to reaching a decision with regards to the approval of a cervical cancer drug manufactured by pharmaceutical giant, Merck. The drug is actually a vaccine that is designed to protect against various viruses that can lead to cervical cancer. Gardasil protects against four different viruses that are associated with cervical cancer.

The outside panel of experts used by the FDA in the approval of medication has already given approval to the vaccine, and the final decision from the FDA is expected around June 8th. Although there are some concerns being investigated at the moment, it is thought that the FDA will ultimately go with the decision of the outside panel and give approval to the vaccine.

Some of the concerns surrounding the vaccine include the age group identified for treatment, how smear testing will be affected by the vaccine, how the drug will affect those that already have infections, and the implications with regards to congenital defects in pregnant women.

The treatment will be given over a six month period in three shots, and is likely to cost around three hundred and fifty dollars. Experts think that the massive sales that could be generated by this drug could help Merck to recoup some of the losses stemming from its controversial painkiller, Vioxx.

FDA Close To Decision... | Printable Version (Opens In New Window)

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