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WESTWOOD SQUIBB ULTRAVATE (HALOBETASOL PROPIONATE) APPROVED

Executive Summary

WESTWOOD SQUIBB ULTRAVATE (HALOBETASOL PROPIONATE) APPROVED by FDA on Dec. 17. The corticosteroid halobetasol propionate 0.05% ointment was approved after a 21-month review period. According to approved labeling, Ultravate is "a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses." FDA classified the product as a "1-C," a new chemical entity representing little or no therapeutic gain. The corticosteroid will be launched in January at a price to wholesalers of $14.25 for a 15 gm tube and $28.50 for a 45 gm tube. Bristol-Myers Squibb licenses Ultravate from Ciba-Geigy and has exclusive rights to market the drug in the U.S. Westwood Squibb, the company's dermatologics division, will market the ointment. Westwood Squibb is an entity resulting from the merger of Bristol-Myers with Squibb in which Bristol-Myers' subsidiary Westwood Pharmaceuticals was combined with Squibb dermatologics business. Ultravate fits into the line of topical corticosteroids marketed by Westwood Squibb. Those products include Westwood's Westcort (hydrocortisone valerate) 0.2% ointment and cream, Squibb's Kenalog (triamcinolone acetonide) topical products ranging from 0.025% to 0.5% in potency and Halog (halcinonide) 0.025% and 0.1% products. The company has an application pending at FDA for a cream form of Ultravate. Westwood Squibb said that the corticosteroid's approval was supported by vasoconstrictor tests as well as clinical studies done in disease states. Ultravate's labeling says that "treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 gm/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis." The labeling also contains a general warning that use of topical corticosteroids can cause "reversible hypothalamic-pituitary-adrenal (HPA) axis supression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment." Specifically, the labeling states that Ultravate "produced HPA axis suppression when used in divided doses at 7 grams per day for one week in patients with psoriasis." Also the labeling warns that "patients receiving super-potent corticosteroids should not be treated for more than two weeks at a time and only small areas should be treated at any one time due to the increased risk of HPA suppression." Studies of Ultravate in humans and animals "indicate that approximately 3% of the applied dose of halobetasol propionate enters the circulation within 96 hours following topical administration of the ointment," the labeling notes.

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