CEREZYME APPROVED IN USA

Genzyme has received approval from the Food and Drug Administration to market its recombinant version of glucocerebrosidase, Cerezyme, for the treatment of Gaucher's disease. The company also markets a naturally-derived version of the drug called Ceredase (alglucerase), which was introduced in the USA in 1991.

The approval of Cerezyme was based on a Phase III study comparing the recombinant version to Ceredase, which involved 30 patients. The patients, who were split evenly between the two treatments, received repeated doses of the drugs over a period of six to nine months. The study found that fewer patients in the Cerezyme-treated arm had antibody reactions against the treatment than those who received Ceredase (16% versus 40%).

One of the Ceredase-treated patients had clinically significant allergic symptoms and signs which required withdrawal from the trial. No patient was withdrawn from the Cerezyme arm, although one developed a mild rash, and labeling for the drug notes that immediate hypersensitivity reactions may occur and should be watched for.