UCB/Sanofi’s Xyzal Clears FDA As Once-Daily Antihistamine
This article was originally published in The Pink Sheet Daily
Executive Summary
Xyzal will be available for the fall allergy season after being approved for symptoms associated with seasonal and perennial allergic rhinitis.
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UCB and Sanofi-Aventis plan to launch the antihistamine Xyzal (levocetirizine dihydrochloride) in the U.S. in time for the fall allergy season, the companies said May 29, announcing FDA approval of the once-daily H1 receptor antagonist. FDA approved Xyzal tablets May 25 for the relief of symptoms associated with seasonal and perennial allergic rhinitis and for the treatment of uncomplicated skin manifestations of chronic urticaria in adults and children six years of age and older. The two companies plan to jointly promote Xyzal in the U.S. using a combined field force of 1,000 sales representatives, Sanofi told "The Pink Sheet" DAILY. Sanofi entered into a joint marketing agreement with Belgium-based UCB for Xyzal in September after UCB had already submitted the NDA for the allergy medication to FDA in July (1 (Also see "UCB’s Next Allergy Partner Is Sanofi-Aventis" - Pink Sheet, 25 Sep, 2006.)). The firms have not planned a direct-to-consumer marketing campaign to promote the launch. However, Sanofi said it will continue to evaluate DTC as the launch proceeds. The timing of the introduction will fall just ahead of when UCB's Zyrtec (cetirizine) is scheduled to go off patent later this year. Pfizer markets the drug under a copromotion agreement with UCB. Sanofi's antihistamine Allegra (fexofenadine), meanwhile, went off patent in 2005, although Sanofi still markets Allegra-D (fexofenadine/pseudophedrine). It is unclear exactly how UCB and Sanofi plan to compete against existing H1 receptor antagonists that are off patent. Johnson & Johnson, for example, is planning to launch over-the-counter Zyrtec in late 2007 after acquiring the OTC licensing rights through its purchase of Pfizer Consumer Healthcare in December. Sanofi, however, is pushing Xyzal's long-lasting effect and quick onset of action as benefits for treating challenging allergies. Dosing of the medication is one 5 mg tablet once daily in the evening for patients 12 years of age and older, and one-half tablet, 2.5 mg, for children six to 11. Warnings included in the prescribing information for Xyzal include occurrence of somnolence, fatigue and asthenia. "Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as operating machinery or driving a motor vehicle after ingestion of Xyzal," according to labeling. FDA approval was based on eight clinical trials in which 1,896 patients were treated with Xyzal 2.5 mg, 5 mg or 10 mg once daily. Six randomized, placebo-controlled, double-blind clinical studies evaluated Xyzal in patients 12 and older with symptoms of seasonal or perennial allergic rhinitis. The trials showed that Xyzal demonstrated greater decrease in the reflective total symptom score than placebo, and the difference was statistically significant for all three doses in two of the studies. Two additional studies evaluated the drug for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in patients 18 to 85 years of age, with Xyzal demonstrating greater decreases in the reflective pruritus severity score than placebo. Xyzal has been approved in Europe since 2001 and is currently marketed in more than 80 countries. -Jessica Merrill ([email protected]) |