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HEALTH : FDA Panel Approves Abbott’s Asthma Drug : Pharmaceuticals: The agency is likely to give final OK to Leutrol. A huge sales potential is seen.

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From Bloomberg Business News

Abbott Laboratories on Monday received approval from a Food and Drug Administration advisory panel to sell a new class of asthma drug.

Abbott’s zileuton, which would be sold under the brand name Leutrol, inhibits the production of a naturally occurring substance believed to cause inflammation of the airways in the lungs.

The panel’s action must be approved by the FDA before Abbott can sell the drug, but the agency usually takes the advice of its advisory panels.

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Analysts have said the U.S. sales potential for the new class of drug could be several hundred million dollars annually. However, they have pointed out that the revenue potential could be reduced if approval is limited to use for severe asthma.

The panel made no such limitation, despite some members’ concerns about the drug’s effect on the liver.

The Abbott Park, Ill.-based company said studies of patients given Leutrol found a “significant decrease” in daily and nightly asthma symptoms and that the drug was well tolerated. The company said patients responded to the drug two to four weeks after starting on it.

Analysts are bullish about the future of the drug but also expressed caution about its initial use.

Leutrol attacks inflammation more directly than other popular asthma drugs on the market.

“This represents the leading edge of important improvements in oral asthma therapy,” said Neil B. Sweig, drug industry analyst with Ladenburg, Thalmann & Co. in New York.

Glaxo, which has the largest share of the $6.7-billion worldwide asthma prescription drug market, and Merck & Co., Upjohn Co. and others are also developing this class of drug, he said.

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“If it is more of a rifle-shot approach, versus shotgun, you have increased opportunity to reduce the inflammation process,” Sweig said.

The market potential for an improved asthma drug is huge. About 10 million Americans, including 3 million children, have asthma, which causes breathing difficulties. The condition is said to be related to about 5,000 deaths annually in the United States. Asthma-related deaths have increased more than 30% since 1980, and doctors do not entirely know why.

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