FDA OKs UCB/Sanofi's Xyzal for allergies

Belgian drugmaker UCB and French pharmaceutical major Sanofi-Aventis say that the US Food and Drug Administration has approved Xyzal (levocetirizine dihydrochloride) for seasonal and perennial allergic rhinitis. The approval also covers the drug's use in the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria.

Xyzal, which was originally filed with the FDA last summer (Marketletter August 7, 2006), is covered by a co-promotion agreement that the firms established late last year. US regulatory approval is primarily based on data from eight trials in which the drug significantly reduced allergy symptoms. Patients suffering from CIU experienced a reduction in both the severity of itching and the number and size of wheals characteristic of the condition.

The firms added that they plan to launch the once-daily tablet version of the drug in time for the 2007 fall allergy season. The product has been available in Europe since 2001, and is sold in over 80 countries worldwide.