Abbott Submits NDA For Zileuton

Abbott Laboratories has submitted a New Drug Application to the US Food and Drug Administration for its 5-lipoxygenase inhibitor Leutrol (zileuton) for the treatment of asthma. It is the first regulatory submission for a 5-LO inhibitor.

Zileuton acts by inhibiting production of leukotrienes (LTB4, LTC4, LTD4 and LTE4), a group of substances which are believed to play a role in inflammation, and have been implicated in a number of disease processes including asthma.

The company says that controlled studies in chronic, stable asthma patients suggest that treatment with zileuton improves lung function significantly. In addition, results from a six-month study showed that improvement is sustained with continued treatment. Patients treated with zileuton, according to the company, experience a significant decrease in daily and nocturnal asthma symptoms, a decrease in the use of inhaled beta agonists, and a decrease in corticosteroid rescue therapy for acute asthmatic exacerbation.