Accolate Cleared In USA For Asthma; 1st In Class

Zeneca's leukotriene D4 receptor antagonist Accolate (zafirlukast) has been approved for marketing in the USA for the preventive and chronic treatment of asthma in adults and children 12 years of age and older. Accolate becomes the first member of this class to be cleared in the USA.

The USA is the third country to approve the drug worldwide. It was approved and launched in Ireland and Finland earlier this year, according to Zeneca. A launch in the USA is scheduled for November 1, and the company says it intends to self-market the product for the time being. Zeneca would not disclose its pricing strategy, but in Ireland, its first market, Accolate costs around 70p ($1.09) a day.

Accolate, which is taken orally twice-daily, achieved a broader indication than might have been expected from comments at the US Food and Drug Administration advisory committee meeting held earlier this year (Marketletter April 8), when Zeneca presented data showing that Accolate improved lung function and reduced daytime and night-time asthma symptoms in patients with mild-to-moderate asthma. On the strength of this, the panel agreed that the drug was efficacious in these patients, but asked for more data on potential drug interactions, specifically with warfarin, terfenadine and astemizole.