- Approximately 70% of Lemtrada Patients Had Not Received Any
Additional Lemtrada Treatment in the Prior Three Years -
Company Website:
http://www.genzyme.com
CAMBRIDGE, Mass. -- (Business Wire)
Genzyme,
a Sanofi
company, announced that new magnetic resonance imaging (MRI) data from
the Lemtrada® (alemtuzumab) clinical development
program will be presented today at the 67th American Academy of
Neurology (AAN) Annual Meeting.
In relapsing remitting multiple sclerosis (RRMS) patients treated with
Lemtrada in the Phase III pivotal studies, MRI effects observed in the
two-year trials were maintained through two additional years in the
extension study (years three and four). After the initial two courses of
treatment in the pivotal studies, which were given at month zero and at
month 12, approximately 70 percent of Lemtrada patients did not receive
additional Lemtrada treatment during the following three years, through
month 48.
The Phase III trials of Lemtrada were randomized, two-year pivotal
studies comparing treatment with Lemtrada to high-dose subcutaneous
interferon beta-1a (Rebif®) in patients with RRMS who had
active disease and were either new to treatment (CARE-MS I) or who had
an inadequate response to another therapy (CARE-MS II).
Through year four, the adverse event profile of Lemtrada was consistent
with that observed during the pivotal studies. The new data being
presented at AAN include:
-
The rate of brain atrophy, as measured by brain parenchymal fraction
(BPF), decreased progressively over four years among Lemtrada patients
in CARE-MS I. Among CARE-MS II Lemtrada patients, the rate of brain
atrophy decreased progressively over three years and remained low in
year four. In both studies, the median yearly brain volume loss was
less than -0.20% in years three and four, which was lower than what
was observed during the two-year pivotal studies.
-
In CARE-MS I and II, treatment with Lemtrada significantly reduced the
risk of developing new lesions compared to interferon beta-1a. In the
extension study, most of the Lemtrada-treated patients from CARE-MS I
and II were free of new lesions and MRI activity in years three and
four (approximately 70%).
Brain atrophy is a measure of the most destructive pathological
processes that occur in MS.1 It is seen from the earliest
stages of disease and may lead to irreversible neurological and
cognitive impairment. Given its association with disability, control or
prevention of brain atrophy is an important target for MS treatment. In
addition, MRI measures including lesion activity are considered useful
tools when evaluating the effect of MS therapies, and lesion activity is
among several prognostic factors for unfavorable clinical outcomes.
2
“It is very promising that most Lemtrada patients experienced slowing
of brain atrophy and remained free of new lesions despite receiving
their last treatment course three years previously,” said Dr.
Alasdair Coles, Professor, Department of Clinical Neurosciences,
University of Cambridge. “These new MRI data are consistent with the
clinical data from the extension study that provide additional evidence
of the sustained efficacy of Lemtrada on both relapses and disability.”
Safety results from the second year of the extension study were
previously reported. No new risks were identified. The most common side
effects of Lemtrada are rash, headache, pyrexia, nasopharyngitis,
nausea, urinary tract infection, fatigue, insomnia, upper respiratory
tract infection, herpes viral infection, urticaria, pruritus, thyroid
gland disorders, fungal infection, arthralgia, pain in extremity, back
pain, diarrhea, sinusitis, oropharyngeal pain, paresthesia, dizziness,
abdominal pain, flushing, and vomiting. Other serious side effects
associated with Lemtrada include autoimmune thyroid disease, autoimmune
cytopenias, infections and pneumonitis. A risk management program
incorporating education and monitoring helps support early detection and
management of these identified risks (see Important Safety Information
About Lemtrada for U.S. Patients below).
“The four-year MRI data support the prolonged efficacy of Lemtrada,”
said Genzyme President and CEO, David Meeker, M.D. “These results are
encouraging, as they provide further evidence of Lemtrada’s potential to
change the treatment approach for people living with relapsing forms of
MS.”
More than 90 percent of the patients who were treated with Lemtrada in
the CARE-MS Phase III trials enrolled in the extension study. These
patients were eligible to receive additional treatment with Lemtrada in
the extension study if they experienced at least one relapse or at least
two new or enlarging brain or spinal cord lesions. MRI scans were taken
at CARE-MS baseline, and at 12, 24, 36 and 48 months.
In CARE-MS I, Lemtrada was significantly more effective than interferon
beta-1a at reducing annualized relapse rates; the difference observed in
slowing disability progression did not reach statistical significance.
In CARE-MS II, Lemtrada was significantly more effective than interferon
beta-1a at reducing annualized relapse rates, and accumulation of
disability was significantly slowed in patients given Lemtrada vs.
interferon beta-1a.
Lemtrada® (alemtuzumab) U.S. Indication and
Usage
Lemtrada is indicated in the United States for the treatment of patients
with relapsing forms of multiple sclerosis (MS). Because of its safety
profile, the use of Lemtrada should generally be reserved for patients
who have had an inadequate response to two or more drugs indicated for
the treatment of MS. Lemtrada is contraindicated in patients who are
infected with Human Immunodeficiency Virus (HIV) because Lemtrada causes
prolonged reductions of CD4+ lymphocyte counts.
Please click here for
full U.S. Prescribing Information for Lemtrada, including boxed warning
and contraindications.
Important Safety Information About Lemtrada for U.S. Patients
Serious and life-threatening autoimmune conditions such as immune
thrombocytopenia (ITP) and anti-glomerular basement membrane disease can
occur in patients receiving Lemtrada. Monitor complete blood counts with
differential, serum creatinine levels, and urinalysis with urine cell
counts at periodic intervals in patients who receive Lemtrada. Lemtrada
is associated with serious and life-threatening infusion reactions.
Lemtrada can only be administered in certified healthcare settings that
have on-site access to equipment and personnel trained to manage
anaphylaxis and serious infusion reactions. Lemtrada may be associated
with an increased risk of malignancy, including thyroid cancer, melanoma
and lymphoproliferative disorders. The Lemtrada REMS Program, a risk
management program with frequent monitoring, has been implemented to
help mitigate these serious risks.
The Lemtrada label includes a boxed warning noting a risk of serious,
sometimes fatal autoimmune conditions, serious and life-threatening
infusion reactions and also noting Lemtrada may cause an increased risk
of malignancies including thyroid cancer, melanoma and
lymphoproliferative disorders. Lemtrada is contraindicated in patients
with Human Immunodeficiency Virus (HIV) infection.
About Lemtrada® (alemtuzumab)
Lemtrada is approved in more than 40 countries, with additional
marketing applications under review. Lemtrada is supported by a
comprehensive and extensive clinical development program that involved
nearly 1,500 patients and 5,400 patient-years of follow-up.
Alemtuzumab is a monoclonal antibody that targets CD52, a protein
abundant on T and B cells. Circulating T and B cells are thought to be
responsible for the damaging inflammatory process in MS. Although the
exact mechanism of action for alemtuzumab is unknown, it is presumed to
deplete circulating T and B lymphocytes after each treatment course.
Lymphocyte counts then increase over time with a reconstitution of the
lymphocyte population that varies for the different lymphocyte subtypes.
Genzyme holds the worldwide rights to alemtuzumab and has responsibility
for its development and commercialization in multiple sclerosis. Bayer
Healthcare receives contingent payments based on global sales revenue.
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 Lemtrada® are registered
trademarks of Genzyme Corporation. Rebif® is a registered
trademark of EMD Serono, Inc. All rights reserved.
About Sanofi
Sanofi, a 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).
References
(1) American Journal of Neuroradiology, August 2014 http://ajnrdigest.org/brain-atrophy-multiple-sclerosis/
(2) Cleveland Clinic, Center For Continuing Education, Medical
Publications, Multiple Sclerosis, June 2014 http://www.clevelandclinicmeded.com/medicalpubs/diseasemanagement/neurology/multiple_sclerosis/
Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in
the Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical facts.
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management believes that the expectations reflected in such
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and uncertainties, many of which are difficult to predict and generally
beyond the control of Sanofi, that could cause actual results and
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risks and uncertainties include among other things, the uncertainties
inherent in research and development, future clinical data and analysis,
including post marketing, decisions by regulatory authorities, such as
the FDA or the EMA, regarding whether and when to approve any drug,
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candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential of
such product candidates, the absence of guarantee that the product
candidates if approved will be commercially successful, the future
approval and commercial success of therapeutic alternatives, the Group's
ability to benefit from external growth opportunities, trends in
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of shares outstanding as well as those discussed or identified in the
public filings with the SEC and the AMF made by Sanofi, including those
listed under "Risk Factors" and "Cautionary Statement Regarding
Forward-Looking Statements" in Sanofi's annual report on Form 20-F for
the year ended December 31, 2014. Other than as required by applicable
law, Sanofi does not undertake any obligation to update or revise any
forward-looking information or statements.
Contacts:
Genzyme Media Relations
Erin Pascal, + 1 857-248-0874
erin.pascal@genzyme.com
or
Sanofi
Media Relations
Jack Cox, +33 (0) 1 53 77 46 46
mr@sanofi.com
or
Sanofi
Investor Relations
Sébastien Martel, +33 (0) 1 53 77 45 45
ir@sanofi.com
Source: Genzyme
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