– At six years in the extension of two Phase
III pivotal studies, 64 and 55 percent of Lemtrada-treated patients
received no additional Lemtrada in the prior five years –
– Consistent effects seen across relapse,
disability, brain atrophy and MRI lesion activity –
Sanofi and its specialty care global business unit Sanofi
Genzyme announced today positive new six-year investigational data
from the extension study of Lemtrada® (alemtuzumab) in
patients with relapsing remitting multiple sclerosis (RRMS). These
results will be presented today at the 32nd Congress of the
European Committee for Treatment and Research in Multiple Sclerosis
(ECTRIMS) in London.
In RRMS patients treated with Lemtrada in the CARE-MS Phase III
pivotal studies, the effects described below observed in the
two-year trials were maintained through four additional years in
the extension study. More than 90 percent of the patients who were
treated with Lemtrada in the CARE-MS trials enrolled in the
extension. These patients were eligible to receive additional
treatment with Lemtrada in the extension if they experienced at
least one relapse or at least two new or enlarging brain or spinal
cord lesions.
After the initial two courses of treatment in the CARE-MS
trials, which were given at month zero and at month 12, 64 percent
of Lemtrada patients from CARE-MS I and 55 percent from CARE-MS II
did not receive additional Lemtrada treatment during the following
five years, through month 72.
- The low annualized relapse rates
observed in patients who received Lemtrada in the Phase III studies
CARE-MS I (0.16) and CARE-MS II (0.28) remained consistent
throughout the extension (0.12 and 0.15 at year six.)
- Through year six, 77 percent and 72
percent of patients who received Lemtrada in CARE-MS I and CARE-MS
II, respectively, did not experience worsening of six-month
confirmed disability as measured by the Expanded Disability Status
Scale (EDSS).
- Through year six, 34 percent and 43
percent of patients who had disability before receiving Lemtrada in
CARE-MS I and CARE-MS II, respectively, had improvement in EDSS
score confirmed over at least six months as compared with
pre-treatment baseline.
- Through year six, patients who received
Lemtrada in CARE-MS I and II experienced a slowing of brain atrophy
as measured by brain parenchymal fraction on magnetic resonance
imaging (MRI). In years three through six, the median yearly brain
volume loss was -0.20 percent or less, which was lower than what
was observed in the Lemtrada-treated patients during the two-year
pivotal studies (CARE-MS I: -0.59 percent in year one; -0.25
percent in year two; CARE-MS II: -0.48 percent in year one; -0.22
percent in year two).
- In each of years three, four, five and
six, most patients had no evidence of MRI disease activity, defined
as no new gadolinium-enhancing T1 lesions and no new or enlarging
T2 lesions (66 – 72 percent, CARE-MS I; 68 – 70 percent, CARE-MS
II).
Through year six, the yearly incidence of most adverse events
during the extension study was comparable or reduced compared with
the pivotal studies. The frequency of thyroid adverse events was
highest in year three and declined thereafter.
“The Lemtrada data being presented at ECTRIMS from the ongoing
extension study illustrate that more than half of patients
experienced sustained effects of treatment on disease activity,
despite receiving their last treatment course five years
previously,” said Dr. Alasdair Coles, Professor, Department of
Clinical Neurosciences, University of Cambridge. “It is very
promising to see these consistent effects over time across relapse,
disability and MRI measures.”
The Phase III trials of Lemtrada were randomized, rater-blinded,
two-year pivotal studies comparing treatment with Lemtrada to
high-dose subcutaneous interferon beta-1a 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).
Active disease was defined as at least two relapses in the previous
two years and at least one in the previous year. The protocol
called for Lemtrada to be administered as two annual treatment
courses, with the first treatment course administered via
intravenous infusion on five consecutive days, and the second
course administered on three consecutive days, 12 months later.
In clinical trials, serious side effects associated with
Lemtrada included infusion reactions, autoimmune disorders (such as
thyroid disease, autoimmune cytopenias, and nephropathies),
infections and pneumonitis. Lemtrada may cause an increased risk of
malignancies. 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. More than 9,200
patients have been treated with Lemtrada commercially
worldwide.
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.
Sanofi 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
• fast, slow, or irregular heartbeat
• trouble breathing
• chest pain
• weakness
• 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
• trouble swallowing or breathing
• swelling in your neck
• cough that is not caused by a cold
• pain in front of neck
• hoarseness or other voice changes that do not go away
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 gain
• unexplained weight loss
• feeling cold
• eye swelling
• worsening tiredness
• nervousness
• constipation
• fast heartbeat
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
• dark urine
• chest pain
• fast heartbeat
• yellowing of the skin or whites of the eyes (jaundice)
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
• chest pain or tightness
• cough
• coughing up blood
• wheezing
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 see full U.S. Prescribing Information,
including boxed WARNING and Medication Guide.
About Sanofi
Sanofi, a global healthcare leader, discovers, develops and
distributes therapeutic solutions focused on patients' needs.
Sanofi is organized into five global business units: Diabetes and
Cardiovascular, General Medicines and Emerging Markets, Sanofi
Genzyme, Sanofi Pasteur and Merial. 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 a registered 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,
Sanofi's ability to benefit from external growth opportunities
and/or obtain regulatory clearances, risks associated with
intellectual property and any related pending or future litigation
and the ultimate outcome of such litigation, trends in exchange
rates and prevailing interest rates, volatile economic conditions,
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.
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