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Gilead to appeal FDA request

17th November 2008

Gilead Sciences has said that it plans to appeal a request by the US Food and Drug Administration (FDA) for an additional study.

The research asked for would be clinical examination of the company’s experimental cystic fibrosis drug.

It follows the administration’s decision in September that it would not approve the drug, unless an additional trial was conducted.

According to Reuters, this surprised analysts, who added that the request would delay the launch of the drug by two years.

Speaking to the news agency, Gilead’s Cara Miller said: “Gilead intends to appeal the decision with the FDA on the basis of what we believe is the strength of the efficacy and safety of aztreonam lysine and of its overall clinical profile as outlined in our new drug application.”

The drug would be used to treat lung infections associated with cystic fibrosis – a genetic disease which makes the body produce thicker mucus that can clog up the lungs and other organs.

Based in Foster City, US, Gilead Sciences has a workforce of more than 3,400 employees and has operations in North America, Europe and Australasia.

The company’s revenues now exceed $4 billion (2.69 billion pounds).

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