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Genzyme secures regulatory approval for product label expansion

Sanofi company, Genzyme has received approval of a product label expansion from the European Commission for the use of Thyrogen (thyrotropin alfa) with a broad irradiation dose range for postoperative thyroid remnant ablation.

The revised labeling provides an option to the physicians to manage a reduced dose of radioiodine (131-I), which was earlier specified at 100 mCi. Physicians may now select a dose from the range of 30 to 100 mCi.

The expanded Thyrogen indication provides a new option for physicians who may be reducing radioiodine use owing to ambiguity about impact on recurrences and mortality in low-risk patients as well as short and long-term safety concerns.

According to the company, the decision to approve the expanded labeling for use of the product in Europe is based on the results of the two studies including HiLo and ESTIMABL.

In order to avoid temporarily discontinuing thyroid replacement therapy for postoperative thyroid remnant ablation, Thyrogen is used before radioiodine treatment.