FDA denies fast-track process to cervical cancer drug
LONDON (AP) — GlaxoSmithKline PLC revealed yesterday that the US 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 US 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 US sometime in 2008.
The company applied for US 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.
The decision on Cervarix comes as the company defends its diabetes drug Avandia after a study published in the New England Journal of Medicine last week said that people taking the drug are at greater risk of heart attacks.
The findings hit Avandia sales hard, with a report from market intelligence group Impact RX showing that the drug's share of the market for newly prescribed oral anti-diabetics fell to around zero from around 10 percent in the two days after the article was published.
