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GENZYME CEREDASE LABELING CHANGE TO REFLECT LOWER DOSAGE

Executive Summary

GENZYME CEREDASE LABELING CHANGE TO REFLECT LOWER DOSAGE range is being developed in conjunction with FDA, Genzyme said June 17. The firm said it met with the agency in May to review all available data on Ceredase (alglucerase) dosing. FDA and the firm have agreed in general on a change, Genzyme said. Specific language should be hammered out shortly, the company added. Genzyme wants labeling to reflect that doses of 15-60 U/kg every two weeks may be effective starting doses. Current Ceredase labeling states that "an initial dosage up to 60 U/kg of body weight per infusion may be used." The low end of the new labeled dose range would reflect results from a Scripps Research Institute study published in the New England Journal of Medicine Dec. 3 ("The Pink Sheet" Dec. 7, 1992, p. 9). That study concluded that a dosing schedule of 2.3 U/kg three times a week may be "a reasonable compromise between high costs and the convenience of the patient." Genzyme said it first approached FDA to work on changing Ceredase dosage labeling last autumn, but that data available then were too sketchy to support a clear statement. The firm believes that there is no one optimal dose of Ceredase but that treatment must be individualized. The effort to reduce the labeled dosage range for the Gaucher's disease treatment was cited by Rep. Wyden (D-Ore.) during a June 17 hearing on government/academe/industry research collaborations (see related stories, p. 8-10). "FDA is asking the manufacturer of Ceredase to change its labeling with regard to lowering prescribed dosage levels," Wyden said. Such a change would be "a real boon to consumers who are now paying as much as $360,000 per year for this medication." Genzyme has faced rhetorical attacks for its Ceredase pricing since the drug was launched in mid-1991. The firm reported in April that the 800 patients on Ceredase are paying an average of $140,000 per year for therapy "and that [the price] is declining" ("The Pink Sheet" April 5, In Brief). Genzyme argues that annual maintenance therapy costs may fall as low as $20,000-$60,000 per patient.
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