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US approval for HPV vaccine delayed


Pharmaceutical giant GlaxoSmithKline (GSK) has announced that it does not expect to be given US approval for a new HPV vaccine until the end of next year.

The firm has said it will wait until results from a phase III trial of the Cervarix vaccine are available before it seeks approval from the country’s Food and Drug Administration (FDA). Cervarix has already been approved in almost 70 countries, including Europe.

The drug was recently selected to be given to girls in Britain aged 12 and 13 from this September in an attempt to cut the number contracting human papillomavirus (HPV), which causes most cases of cervical cancer.

HPV strains 16 and 18 cause about 70% of cervical cancer cases and both GSK and rival Merck are competing for vaccination contracts worldwide. Cervarix and Merck’s Gardasil vaccine are both targeted towards girls and young women and have been found to be 100% effective in preventing infection from the two strains.

Last December the FDA asked for additional information about Cervarix before it would issue a decision on GSK’s application. Earlier this year the company said it would provide the information by this autumn, but it has now announced its intention to wait until the phase III trial results are available. It expects the trial to find a longer duration of safety and efficacy compared with other drugs such as Gardasil.

Copyright PA Business 2008

US Food and Drug Administration

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