Breaking News

Tweet TWEET

Genzyme Receives European Label Expansion for Thyrogen

  Genzyme Receives European Label Expansion for Thyrogen

   Label will Enable Additional Usage in Patients for Postoperative Thyroid
                               Remnant Ablation

Business Wire

CAMBRIDGE, Mass. -- December 07, 2012

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.”

The decision to approve the expanded indication for use of Thyrogen in Europe
is based on the results of the two largest studies (HiLo and ESTIMABL) ever
conducted in thyroid remnant ablation. The studies, published in the New
England Journal of Medicine in May 2012, evaluated whether rates of successful
ablation would be similar among patients receiving recombinant human
thyrotropin (rhTSH), patients undergoing thyroid hormone withdrawal (THW), and
among patients receiving low or high amount of radioiodine.

In the two studies, 30 mCi of radioiodine were well tolerated and showed
similar success rates for low-dose radioiodine plus rhTSH vs. high-dose plus
THW or rhTSH. In both studies, patients receiving Thyrogen rather than THW had
fewer hypothyroid symptoms and better 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 and societal costs, as
demonstrated in the HiLo and ESTIMABL trials,” said Ujjal Mallick, M.D.,
Northern Centre for Cancer Care, Freeman Hospital, Newcastle UK.

These findings have been reflected in the updated Summary of Product
Characteristics (SmPC) and apply to all 27 EU member states, plus Iceland and
Norway.

About Thyrogen

Thyrogen (thyrotropin alfa for injection) is for patients with
well-differentiated thyroid cancer. Thyrogen is approved as an adjunctive
diagnostic tool for serum thyroglobulin (Tg) testing with or without
radioiodine imaging. Thyrogen is also approved in the U.S. and Europe as an
adjunctive treatment for radioiodine ablation of thyroid tissue remnants in
patients who have undergone a near total or total thyroidectomy for
well-differentiated thyroid cancer and who do not have evidence of metastatic
thyroid cancer.

About Genzyme, a Sanofi Company

Genzyme has pioneered the development and delivery of transformative therapies
for patients affected by rare and debilitating diseases for over 30 years. We
accomplish our goals through world-class research and with the compassion and
commitment of our employees. With a focus on rare diseases and multiple
sclerosis, we are dedicated to making a positive impact on the lives of the
patients and families we serve. That goal guides and inspires us every day.
Genzyme’s portfolio of transformative therapies, which are marketed in
countries around the world, represents groundbreaking and life-saving advances
in medicine. As a Sanofi company, Genzyme benefits from the reach and
resources of one of the world’s largest pharmaceutical companies, with a
shared commitment to improving the lives of patients. Learn more at
www.genzyme.com.

Genzyme^® and Thyrogen^® are registered trademarks of Genzyme Corporation. All
rights reserved.

Contact:

Media Contact:
Genzyme
Ingrid Mitchell, 617-768-6699
Ingrid.Mitchell@genzyme.com
 
Press spacebar to pause and continue. Press esc to stop.