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CAMBRIDGE, Mass. -- (Business Wire)
Sanofi
Genzyme, the specialty care global business unit of Sanofi,
today announced that positive new brain volume data from an ongoing
clinical study of Lemtrada® (alemtuzumab) will be presented
at the 68th American Academy of Neurology (AAN) Annual Meeting. In
addition, new data from an exploratory study will be presented which
demonstrate the impact of Lemtrada on retinal nerve fibers.
Lemtrada Investigational Brain Volume Data:
Relapsing-remitting multiple sclerosis (RRMS) patients treated with
interferon beta-1a in CARE-MS I and II for two years who switched to
Lemtrada in the extension study experienced a reduced rate of brain
volume loss over the next three years.
Median yearly brain volume loss in interferon beta-1a treated patients
in year two in CARE-MS I (-0.50%) and CARE-MS II (-0.33%) was reduced in
years one, two and three after switching to Lemtrada (CARE-MS I: -0.07%,
-0.13%, -0.09%; CARE-MS II: 0.02%, -0.05%, -0.14%).
Lemtrada Investigational Retinal Data: A
measurable improvement in retinal nerve fiber layer (RNFL) thickness was
seen in 26 Lemtrada-treated RRMS patients. Over two years, the change in
average RNFL thickness for all eyes was +1.5 micrometers (95% CI 0.2,
2.9; p=0.032). The observed thickening of retinal fibers may reflect
protection of retinal axons in these patients.
“The Lemtrada data being presented at AAN from the ongoing extension
study demonstrating slowed brain volume loss over three years are
consistent with sustained effects seen in prior clinical, imaging and
atrophy analyses,” said Dr. Anthony Traboulsee, Associate Professor
of Neurology and Medical Director of the UBC Hospital MS Clinic of
Vancouver Coastal Health. “In addition, given the critical importance
of neuroprotection in the treatment of MS, the retinal nerve fiber data
are also exciting and support further investigation.”
In clinical trials, serious side effects associated with Lemtrada
included infusion-associated reactions, autoimmune disorders (such as
thyroid disease, autoimmune cytopenias, and nephropathies), infections
and pneumonitis. Risk management programs incorporating education and
monitoring help support early detection and management of key identified
and potential risks. 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. (See Important Safety Information below.)
About Lemtrada® (alemtuzumab)
Lemtrada
is approved in more than 50 countries, with additional marketing
applications under review by regulatory authorities globally. Lemtrada
is supported by a comprehensive and extensive clinical development
program that involved nearly 1,500 patients worldwide and 5,400
patient-years of follow-up.
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.
The precise mechanism by which alemtuzumab exerts its therapeutic
effects in MS is unknown. 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. Lemtrada depletes 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.
Lemtrada® (alemtuzumab) U.S. Indication
LEMTRADA
is a prescription medicine used to treat adults with relapsing forms of
multiple sclerosis (MS). Because of its risks, LEMTRADA is generally
used in people who have tried 2 or more MS medicines that have not
worked well enough. It is not known if LEMTRADA is safe and effective
for use in children under 17 years of age.
Do not receive LEMTRADA if you are infected with human
immunodeficiency virus (HIV).
IMPORTANT SAFETY INFORMATION
LEMTRADA can cause serious side effects including:
Serious autoimmune problems: Some people receiving LEMTRADA
develop a condition where the immune cells in your body attack other
cells or organs in the body (autoimmunity), which can be serious and may
cause death. Serious autoimmune problems may include:
• Immune thrombocytopenia, which is when reduced platelet counts in your
blood cause severe bleeding that, if not treated, may cause
life-threatening problems. Call your healthcare provider right away if
you have any of the following symptoms: easy bruising; bleeding from a
cut that is hard to stop; heavier menstrual periods than normal;
bleeding from your gums or nose that is new or takes longer than usual
to stop; small, scattered spots on your skin that are red, pink, or
purple
• Kidney problems called anti-glomerular basement membrane disease,
which can, if untreated, lead to severe kidney damage, kidney failure
that needs dialysis, a kidney transplant, or death. Call your healthcare
provider right away if you have any of the following symptoms: blood in
the urine (red or tea-colored urine); swelling of legs or feet; coughing
up blood
It is important for you to have blood and urine tests before you
receive, while you are receiving and every month, for 4 years or longer,
after you receive your last LEMTRADA infusion.
Serious infusion reactions: LEMTRADA can cause serious infusion
reactions that may cause death. Serious infusion reactions may happen
while you receive, or up to 24 hours or longer after you receive
LEMTRADA.
• You will receive your infusion at a healthcare facility with equipment
and staff trained to manage infusion reactions, including serious
allergic reactions, and urgent heart or breathing problems. You will be
watched while you receive, and for 2 hours or longer after you receive,
LEMTRADA. If a serious infusion reaction happens while you are receiving
LEMTRADA, your infusion may be stopped.
Tell your healthcare provider right away if you have any of the
following symptoms of a serious infusion reaction during the infusion,
and after you have left the healthcare facility:
• swelling in your mouth or throat
• trouble breathing
• weakness
• fast, slow, or irregular heartbeat
• chest pain
• rash
To lower your chances of getting a serious infusion reaction, your
healthcare provider will give you a medicine called corticosteroids
before your first 3 infusions of a treatment course. You may also be
given other medicines before or after the infusion to try to reduce your
chances of having these reactions or to treat them after they happen.
Certain cancers: Receiving LEMTRADA may increase your chance of
getting some kinds of cancers, including thyroid cancer, skin cancer
(melanoma), and blood cancers called lymphoproliferative disorders and
lymphoma. Call your healthcare provider if you have the following
symptoms that may be a sign of thyroid cancer:
• new lump
• swelling in your neck
• pain in front of neck
• hoarseness or other voice changes that do not go away
• trouble swallowing or breathing
• cough that is not caused by a cold
Have your skin checked before you start receiving LEMTRADA and each year
while you are receiving treatment to monitor for symptoms of skin cancer.
Because of risks of autoimmunity, infusion reactions, and some kinds
of cancers, LEMTRADA is only available through a restricted program
called the LEMTRADA Risk Evaluation and Mitigation Strategy (REMS)
Program.
Thyroid problems: Some patients taking LEMTRADA may get an
overactive thyroid (hyperthyroidism) or an underactive thyroid
(hypothyroidism). Call your healthcare provider if you have any of these
symptoms:
• excessive sweating
• unexplained weight loss
• eye swelling
• nervousness
• fast heartbeat
• unexplained weight gain
• feeling cold
• worsening tiredness
• constipation
Low blood counts (cytopenias): LEMTRADA may cause a decrease in
some types of blood cells. Some people with these low blood counts have
increased infections. Call your doctor right away if you have symptoms
of cytopenias such as:
• weakness
• chest pain
• yellowing of the skin or whites of the eyes (jaundice)
• dark urine
• fast heartbeat
Serious infections: LEMTRADA may cause you to have a serious
infection while you receive and after receiving a course of treatment.
Serious infections may include:
• Herpes viral infections. Some people taking LEMTRADA have an
increased chance of getting herpes viral infections. Take any medicines
as prescribed by your healthcare provider to reduce your chances of
getting these infections.
• Tuberculosis. Your healthcare provider should check you for
tuberculosis before you receive LEMTRADA.
• Hepatitis. People who are at high risk of, or are carriers of,
hepatitis B (HBV) or hepatitis C (HCV) may be at risk of irreversible
liver damage.
These are not all the possible infections that could happen while on
LEMTRADA. Call your healthcare provider right away if you have symptoms
of a serious infection such as fever or swollen glands. Talk to your
healthcare provider before you get vaccinations after receiving
LEMTRADA. Certain vaccinations may increase your chances of getting
infections.
Swelling of lung tissue (pneumonitis): Some people have had
swelling of the lung tissue while receiving LEMTRADA. Call your
healthcare provider right away if you have the following symptoms:
• shortness of breath
• cough
• wheezing
• chest pain or tightness
• coughing up blood
Before receiving LEMTRADA, tell your healthcare provider if you:
• are taking a medicine called Campath® (alemtuzumab)
• have bleeding, thyroid, or kidney problems
• have HIV
• have a recent history of infection
• have received a live vaccine in the past 6 weeks before receiving
LEMTRADA or plan to receive any live vaccines. Ask your healthcare
provider if you are not sure if your vaccine is a live vaccine
• are pregnant or plan to become pregnant. LEMTRADA may harm your unborn
baby. You should use birth control while receiving LEMTRADA and for 4
months after your course of treatment
• are breastfeeding or plan to breastfeed. You and your healthcare
provider should decide if you should receive LEMTRADA or breastfeed. You
should not do both.
Tell your healthcare provider about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal
supplements. LEMTRADA and other medicines may affect each other, causing
side effects. Especially tell your healthcare provider if you take
medicines that increase your chance of getting infections, including
medicines used to treat cancer or to control your immune system.
The most common side effects of LEMTRADA include:
• rash
• headache
• thyroid problems
• fever
• swelling of your nose and throat
• nausea
• urinary tract infection
• feeling tired
• trouble sleeping
• upper respiratory infection
• herpes viral infection
• hives
• itching
• fungal infection
• joint pain
• pain in your arms or legs
• back pain
• diarrhea
• sinus infection
• mouth pain or sore throat
• tingling sensation
• dizziness
• stomach pain
• sudden redness in face, neck, or chest
• vomiting
Tell your healthcare provider if you have any side effect that bothers
you or that does not go away. These are not all the possible side
effects of LEMTRADA.
You are encouraged to report side effects of prescription drugs to
the FDA. Visit http://www.fda.gov/medwatch
or call 1-800-FDA-1088
Please click here for full U.S. Prescribing
Information, including boxed WARNING and Medication
Guide, for additional Important Safety Information.
About Sanofi
Sanofi, a global healthcare leader, discovers,
develops and distributes therapeutic solutions focused on patients'
needs. Sanofi has core strengths in diabetes solutions, human vaccines,
innovative drugs, consumer healthcare, emerging markets, animal health
and Genzyme. Sanofi is listed in Paris (EURONEXT: SAN)
and in New York (NYSE: SNY).
Sanofi Genzyme focuses on developing specialty treatments for
debilitating diseases that are often difficult to diagnose and treat,
providing hope to patients and their families. Learn more at www.sanofigenzyme.com.
Sanofi® is aregistered trademark of Sanofi.
Genzyme® and Lemtrada® are registered trademarks
of Genzyme Corporation. All rights reserved.
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. These
statements include projections and estimates and their underlying
assumptions, statements regarding plans, objectives, intentions and
expectations with respect to future financial results, events,
operations, services, product development and potential, and statements
regarding future performance. Forward-looking statements are generally
identified by the words “expects”, “anticipates”, “believes”, “intends”,
“estimates”, “plans” and similar expressions. Although Sanofi’s
management believes that the expectations reflected in such
forward-looking statements are reasonable, investors are cautioned that
forward-looking information and statements are subject to various risks
and uncertainties, many of which are difficult to predict and generally
beyond the control of Sanofi, that could cause actual results and
developments to differ materially from those expressed in, or implied or
projected by, the forward-looking information and statements. These
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,
device or biological application that may be filed for any such product
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
exchange rates and prevailing interest rates, the impact of cost
containment initiatives and subsequent changes thereto, the average
number 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, 2015. Other than as required by applicable
law, Sanofi does not undertake any obligation to update or revise any
forward-looking information or statements.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160418005384/en/
Contacts:
Sanofi Genzyme
Media Relations
Erin Pascal, + 1
617-768-6864
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: Sanofi Genzyme
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