ROCKVILLE, Md.-The FDA has approved the first fundamentally new asthma drug in more than 20 years.
Zafirlukast (Accolate, Zeneca) became the first leukotriene-receptor antagonist to win the agency’s blessing. Leukotrienes are key mediators in the pulmonary inflammation and bronchospasm typically seen in asthma.
In studies of 4,000 patients worldwide, the twice-daily oral drug improved lung function and reduced symptoms and the need for inhaled medications. Side-effect rates were similar to placebo’s. The drug is indicated as chronic treatment and prophylaxis for patients 12 or over.
The okay follows an advisory panel recommendation that approval be withheld pending studies on zafirlukast’s interactions. In the end, there were no interaction contraindications, but frequent prothrombin times were recommended for those taking warfarin. -Larry Husten
