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ARMOUR's STIMATE (DESMOPRESSIN) APPROVED FOR HEMOPHILIA A

Executive Summary

ARMOUR's STIMATE (DESMOPRESSIN) APPROVED FOR HEMOPHILIA A, von Willebrand's disease (type 1), and diabetes insipidus on March 30. The injectable form of desmopressin should reach trade channels in the next two weeks, Revlon indicated. The product took a little more than a year to make it through FDA following a Jan. 31, 1983 NDA submission. Stimate reached "approvable" status at FDA on Feb. 13 of this year. The FDA approved labeling states that Stimate is "indicated for patients with hemophilia A with factor VIII levels greater than 5% to stop bleeding in hemophilia patients with episodes of spontaneous or trauma-induced injuries." In addition, the labeling notes that Stimate is "indicated in patients with mild-to moderate classic von Willebrand's disease (type 1) with factor VIII levels greater than 5%." The labeling adds: "Stimate will often maintain hemostasis in patients with hemophilia A [and von Willebrand's disease] during surgical procedures and post operatively when administered 30 minutes prior to scheduled procedure." In an April 4 press release announcing the approval, Revlon noted that Stimate "is recommended for short-term use in patients with milder forms of these coagulation disorders who must undergo minor surgery, tooth extractions or have suffered trauma or spontaneous bleeding which, because of the underlying diseases, would otherwise continue to bleed." Revlon pointed out that desmopressin "is not a substitute for the plasma derivatives currently used in the treatment of bleeding disorders of a more severe and protracted nature." Desmopressin is already marketed in an intranasal form by USV for diabetes insipidus under the brandname DDAVP. USV will also market the recently approved injectable form of desmopressin under the brandname DDAVP "for use in patients who are unable to use the intranasal form," Revlon said. DDAVP will carry the new hemophilia A and von Willebrand's labeling as secondary indications, Revlon indicated. While the DDAVP form of desmopressin is marketed by USV, Revlon's Armour subsidiary will add Stimate to its growing line of anti-hemophilia products for the hospital market. The Stimate approval is Armour's second in the past two months in the hemophilia area. In February, Armour received FDA approval for heat-treated versions of its Factorate anti-hemophilic blood component product line. Armour explained at the time that the heat treatment is "intended to reduce the possibility of the transmission of hepatitis, an event frequently encountered with the use of the coagulation factor concentrates." The heat-treated Factorate products are marketed at a slight premium to Armour's standard Factorate line.
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PS006385

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