Glaxo’s cervical cancer vaccine will take longer to get to U.S.

Washington, D.C.

Just when we were talking about delays keeping drug makers’ products from the U.S. market, GlaxoSmithKline announced that its cervical-cancer vaccine Cervarix may take even longer to get to the U.S. than expected.

The company said today that it wants to submit additional data to the FDA, and it now doesn’t expect an FDA decision before late 2009. The FDA had already delayed Cervarix, asking Glaxo for more information.

Now, Glaxo says it has answered the FDA’s questions, but wants to submit more data from a clinical trial that should finish by the end of this year. The clinical trial is measuring Cervarix’s safety and efficacy in thousands of women. Glaxo submitted interim data from the trial with its initial application to the FDA in March 2007.

The development means more profit for Merck, whose blockbuster Gardasil is the only cervical cancer vaccine on the U.S. market. Cervarix is on the market in Europe, Mexico, Australia and parts of Asia.

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