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U.S. Prescribing Information For Thyrogen Revised To Include Use Of Wider Range Of Radioiodine In Patients

Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), today announced the Food and Drug Administration (FDA) approved revised prescribing information for the use of Thyrogen ® (thyrotropin alfa for injection) to widen the dose range of radioiodine (RAI) when used for thyroid remnant ablation. Thyrogen is used before radioiodine treatment to enhance uptake of the radiotracer and allows patients to start and continue taking their thyroid hormone replacement therapy thus avoiding the untoward effects associated with hypothyroidism. Previously the amount of radioiodine was fixed at 100 mCi, whereas physicians may now select a dose from the range of 30-100 mCi.

“The incidence of thyroid cancer is rapidly increasing in the United States,” said Bryan Haugen, M.D., Professor of Medicine at the University of Colorado and immediate past President of the American Thyroid Association. “Today’s FDA revision to widen the administered dose range of RAI for patients being prepared for remnant ablation with Thyrogen allows important management flexibility for physicians and treatment options for patients.”

The revised Prescribing Information (PI) for use of Thyrogen in ablation is based on the results of the two largest prospective studies ever conducted in thyroid cancer. The studies, published in the New England Journal of Medicine in May 2012, compared ablation success among patients receiving recombinant human thyrotropin (rhTSH) and patients undergoing thyroid hormone withdrawal (THW) at both low and high doses of radioiodine. In both studies, patients receiving Thyrogen rather than THW had fewer hypothyroid symptoms and preserved quality of life.

"The best path to achieve thyroid remnant ablation must be one that involves the least whole body radiation dose, the least early and late side-effects, the best quality of life, and the least healthcare costs, as demonstrated in the these two landmark studies,” said Ujjal Mallick, M.D., Northern Centre for Cancer Care, Freeman Hospital, Newcastle UK.

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