Hiccup For Zeneca With FDA Panel Accolate Verdict

At its meeting on March 28, a US Food and Drug Administration advisory panel set conditions for the approval of Zeneca's new orally-active antiasthma drug Accolate (zafirlukast) which could delay its launch onto the US market.

The advisory panel voted by six votes to three to reject the marketing application for asthma treatment as it stood, but recommended that once certain additional data are supplied, Accolate should be approved for use in decreasing the frequency of beta agonist inhaler usage in patients over 12 years of age.

In placebo-controlled trials presented at the advisory committee meeting, Accolate treatment over 13 weeks was found to improve significantly daytime asthma symptom scores, nighttime awakenings, mornings with asthma, beta agonist rescue and peak expiratory flow rates, as well as forced expiratory volumes (FEV1). On average, Accolate reduced the need for beta agonist usage from 7-8 to 5-6 puffs a day.