S-P's Aerius gets expanded EU label

US drug major Schering-Plough says that the European Commission has broadened the indication for Aerius (desloratadine) to cover not only chronic idiopathic urticaria but urticaria, a general term for hives. The agent now has one of the broadest antihistamine labels in the European Union, noted the Kenilworth, New Jersey-based firm.

The new, broader indication of urticaria encompasses different varieties of the disease such as acute, cold-induced, demographic, solar-induced and histamine release in urticaria, in addition to the prior indication of hives of unknown origin.

In two placebo-controlled, six-week trials studying CIU hives of unknown cause - as a model for urticarial conditions, Aerius was effective in relieving pruritus and decreasing the size and number of hives by the end of the first dosing interval. In each trial, the effects were sustained over the 24-hour dosing interval. An improvement in pruritus of more than 50% was observed in 55% of patients treated with desloratadine compared with 19% of those who were given with placebo. Treatment with Aerius also significantly reduced interference with sleep and daytime function, as measured by a four-point scale used to assess these variables, added S-P.