Belgium-based UCB and marketing partner Sanofi-Aventis say that US regulators have given the go-ahead for an oral solution version of their allergy drug Xyzal.
The US Food and Drug Administration has approved Xyzal (levocetirizine) oral solution for the relief of symptoms associated with indoor and outdoor allergies, as well as the treatment of chronic idiopathic urticaria. Xyzal in tablet form received FDA approval in May last year.
Both formulations of Xyzal, which is a follow-up to UCB’s blockbuster antihistamine Zyrtec (cetirizine), are now approved for use in adults and children aged six and over, the firms noted. Studies in allergic rhinitis patients have demonstrated that levocetirizine significantly reduced the symptoms of sneezing, itchy and runny nose, plus itchy eyes.
The companies quoted Michael Blaiss, clinical professor of paediatrics and medicine at the University of Tennessee Health Science Center, as saying that the oral solution of Xyzal “provides a welcome alternative for those patients who have difficulty swallowing or who prefer liquid medication”. He added that both forms offer patients “powerful and long-lasting allergy relief”.
Xyzal was launched in Europe by UCB in 2001 and is currently marketed in over 80 countries worldwide. The US co-marketing deal with Sanofi was signed in September 2006.
