labels: Pharmaceuticals
FDA bars use of Merck's cancer vaccine by women over 27 news
26 June 2008

Mumbai: The US food and Drug Authority (FDA) has issued negative reviews of Merck & Co's cervical cancer vaccine, Gardasil, saying the submitted data did not support approving the drug in non-vaccine HPV types.

FDA also said it found problems with the firm's application to extend the use of the treatment to women between 27 and 45 from its current indication covering ages 9 to 26.

While Gardasil is approved for use in females aged 12 to 26, Merck has been pushing for Gardasil to be approved for women aged 27 to 45.

The FDA has now sent a letter to Merck, stating they need more time to make a decision on the expanded use of Gardasil.

The vaccine is said to offer protection against four types of HPV, two of which lead to cervical cancer.

Merck submitted its application for expanding Gardasil's reach to older women in January, and in March the FDA designated the submission a priority review. The FDA will now take more time than the July deadline anticipated by Merck.

The FDA letter to Merck has identified problems that would delay or deny approval to the therapy within the review timeframe.

Gardasil, approved in 2006 for use in girls and women aged 9 to 26 to prevent cervical cancer caused by the human papillomavirus, is the only FDA-approved cervical cancer vaccine approved for the US market.

Gardasil outsells GlaxoSmithKline Plc's rival vaccine Cervarix globally.

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FDA bars use of Merck's cancer vaccine by women over 27