Schering-Plough's Clarinex will carry the same range of indications as Pfizer's Zyrtec following the approval of desloratadine for perennial allergic rhinitis and chronic idiopathic urticaria.

FDA approved the new indications for Clarinex (NDAs 21-297 and 21-363) Feb. 8. Clarinex was originally approved Dec. 21 for seasonal allergic rhinitis (¹ Also see "Schering-Plough Clarinex Launch Strategy Follows Nexium Model" - Pink Sheet, 7 January, 2002., p. 9).

Clarinex is "indicated for the relief of the nasal and non-nasal symptoms of allergic rhinitis (seasonal and perennial)," labeling states. It is also "indicated for the symptomatic relief of pruritus, reduction in the number of hives and size of hives, in patients with chronic idiopathic urticaria."

In Zyrtec (cetirizine) labeling seasonal and perennial allergic rhinitis appear as different indications, and specific symptoms are listed. For chronic idiopathic urticaria, Zyrtec "is indicated for the treatment of...uncomplicated skin manifestations." The drug "significantly reduces the occurrence, severity and duration of hives and significantly reduces pruritus."

Zyrtec has a broader pediatric indication: it is approved for use in children two and up, while Clarinex is approved for children 12 and up. Schering will submit data on pediatric patients under 12 by Dec. 7, the FDA approval letter for Clarinex indicates.

The new indications will distinguish Clarinex from its predecessor Claritin (loratadine), which is not approved for perennial allergic rhinitis. Aventis' Allegra (fexofenadine) is also labeled only for seasonal allergic rhinitis and chronic idiopathic urticaria.

Schering is touting Clarinex as having the "broadest indications of any nonsedating antihistamine," reflecting the company's position that Zyrtec is in the sedating category.

The new labeling for Clarinex includes data suggesting that the product is safe for use in asthmatics: "In two four-week studies of 924 patients (aged 15 to 75 years) with seasonal allergic rhinitis and concomitant asthma, Clarinex tablets 5 mg once daily improved rhinitis symptoms with no decrease in pulmonary function."

Clarinex' drug interaction section has also been expanded to state that there are no significant interactions with fluoxetine, cimetidine, azithromycin or grapefruit juice. Labeling already noted a lack of interactions with erythromycin and ketoconazole.

Schering-Plough Clarinex Gains Indication Parity With Pfizer’s Zyrtec

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