– 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 –
Company Website:
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PARIS -- (Business Wire)
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 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,
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regarding future performance. Forward-looking statements are generally
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"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 theultimate 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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Contacts:
Sanofi 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
George Grofik, +33 (0) 1 53 77 45 45
ir@sanofi.com
Source: Sanofi Genzyme
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