Sanofi Elitek approved
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Sanofi-Synthelabo's recombinant urate-oxidase enzyme Elitek (rasburicase) is approved July 12 for "initial management of plasma uric acid levels in pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid." Phase IV commitments include development of a validated immunogenicity assay, collecting serum samples from all study patients until the assay is developed, a study in at least 150 patients assessing repetitive treatment with rasburicase, and a study comparing the approved dose and schedule of rasburicase with a regimen of sequential rasburicase and allopurinol, a competing product indicated for hyperuricemia. Sanofi plans to launch Elitek in mid-August. The firm projects worldwide sales will reach EUR 100 mil. in 2005; rasburicase was launched in Europe in 2001 under the brand Fasturtec