Genzyme receives EC approval for Thyrogen product label expansion

Published on December 10, 2012 at 3:21 AM · No Comments

Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), today announced it has received European Commission approval of a product label expansion for the use of Thyrogen® (thyrotropin alfa) with a wider irradiation dose range for postoperative thyroid remnant ablation. Thyrogen is used before radioiodine treatment to avoid temporarily discontinuing thyroid replacement therapy for postoperative thyroid remnant ablation. The revised indication in remnant ablation provides physicians with the option to administer a reduced dose of radioiodine (131-I). Previously the amount of radioiodine was specified at 100 mCi, whereas physicians may now select a dose from the range of 30 to 100 mCi.

"It has long been debated whether smaller amounts of radioiodine for patients with low-risk thyroid cancer would improve care," said Professor Martin Schlumberger, M.D., Institut Gustave Roussy, University Paris Sud, Paris, France. "The expanded Thyrogen indication provides a new option for many physicians who may be reducing radioiodine use due to uncertainty about impact on recurrences and mortality in low-risk patients as well as short- and long-term safety concerns."

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