Abbott Laboratories said Tuesday an FDA advisory committeerecommended approval of Leutrol, which is designed to inhibitleukotriene, for the treatment of asthma.
Abbott, of Abbott Park, Ill., last summer filed a new drug applicationfor Leutrol, the brand name for zileuton.
The Pulmonary and Allergy Drugs Advisory Committee voted 7-to-1in favor of the drug, which blocks the release of an enzyme called 5-lipoxygenase to inhibit formation of leukotrienes.
Although it recommended Leutrol for approval, the committeerequested that the company provide more data on the drug'seffectiveness in treating mild asthma. The advisory committee alsorecommended monitoring patients for adverse side effects,particularly elevated levels of liver enzymes.
Leukotrienes are low-profile, high-potency locally reacting hormonesin the immune system linked to a variety of inflammatory diseases,including asthma.
Abbott said it conducted clinical trials with about 1,000 asthmapatients and the results showed they responded within two weeks ofreceiving the treatment.
In a prepared statement, Bruce Wallin, Abbott's vice president ofimmunoscience, cardiovascular and neuroscience development, said,"Zileuton is thought to treat both the inflammation andbronchoconstriction associated with chronic asthma." _ CharlesCraig
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