AstraZeneca Seeks Approval for Iressa
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AstraZeneca asked the Food and Drug Administration to approve Iressa, a cancer treatment that the company predicts will have sales of more than $1 billion.
The filing asks the regulator to approve the drug to treat advanced non-small-cell lung cancer.
AstraZeneca, Europe’s second-largest drug maker, needs to make up for lower revenue from Prilosec, an ulcer treatment that accounts for about 40% of its sales. Prilosec may soon face cheaper generic rivals, and the British drug maker needs Iressa and other new medicines to fill the gap left by the treatment.
The drug is being studied for the treatment of breast, colo-rectal and gastric cancers, the company said.
The FDA has given Iressa a fast-track designation, which may allow the agency to expedite its review.
AstraZeneca’s ADRs rose $1.34 to $45.94 on the NYSE.
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