Revised label will facilitate use of Thyrogen to greater number of
patients for postoperative thyroid remnant ablation
Company Website:
http://www.genzyme.com
CAMBRIDGE, Mass. -- (Business Wire)
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.
Professor Martin Schlumberger, M.D., Institut Gustave Roussy, University
Paris Sud, Paris, France, said, “The revised PI for Thyrogen provides a
new option for many physicians who may be wanting to reduce radioiodine
use due to uncertainty about impact of dosing on recurrences and
mortality in low-risk patients as well as short- and long-term safety
concerns.”
These findings have been reflected in the clinical studies section in
the updated Full
Prescribing Information.
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 distant 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.
About Sanofi
Sanofi, an integrated global healthcare leader, discovers, develops and
distributes therapeutic solutions focused on patients’ needs. Sanofi has
core strengths in the field of healthcare with seven growth platforms:
diabetes solutions, human vaccines, innovative drugs, consumer
healthcare, emerging markets, animal health and the new Genzyme. Sanofi
is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
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Contacts:
Genzyme
Ingrid Mitchell, 617-768-6699
Ingrid.Mitchell@genzyme.com
Source: Genzyme
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