Gilead To Appeal FDA Demand For More Data

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pleaMaybe a trend is under way. The drugmaker believes its data for a medication to treat cystic fibrosis was sufficient in the first place, even though the agency asked for an additional clinical trial, a request that would likely delay launch of its drug by up to two years.

“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,” a Gilead Sciences spokeswoman e-mailed Reuters.

Gilead applied for approval of the drug to treat lung infections associated with cystic fibrosis and, at the time, the drugmaker said the FDA did not raise any significant concerns regarding the drug’s safety. Prior to the FDA demand, analysts at Oppenheimer estimated that sales of the drug would reach $105 million in 2010, rising to $205 million in 2012.

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