Sanofi: Treatment Effects Maintained Over Six Years in Patients with Relapsing Remitting Multiple Sclerosis who Received Sanofi Genzyme's Lemtrada® (alemtuzumab) in Clinical Trials
(Thomson Reuters ONE) -
Treatment Effects Maintained Over Six Years in Patients with Relapsing Remitting
Multiple Sclerosis who Received Sanofi Genzyme's Lemtrada(®) (alemtuzumab) in
Clinical Trials
- 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 -
Paris, France - September 16, 2016 - 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 32(nd )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 * trouble sleeping * sinus infection
* headache * upper respiratory * mouth pain or sore
infection throat
* thyroid problems * herpes viral infection * tingling sensation
* fever * hives * dizziness
* swelling of your nose * itching * stomach pain
and
throat * fungal infection * sudden redness in
face,
* nausea * joint pain neck, or chest
* urinary tract * pain in your arms or * vomiting
infection legs
* feeling tired * back pain
* diarrhea
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.
Contacts:
Sanofi Genzyme Media Relations
Erin Pascal
Tel: + 1 857 248 0874
E-mail: erin.pascal(at)genzyme.com
Sanofi Media Relations
Jack Cox
Tel: +33 (0) 1 53 77 46 46
E-mail: mr(at)sanofi.com
Sanofi Investor Relations
George Grofik
Tel: +33 (0) 1 53 77 45 45
E-mail: ir(at)sanofi.com
Press Release (PDF):
http://hugin.info/152918/R/2041570/762523.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Sanofi via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 16.09.2016 - 16:30 Uhr
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"Sanofi: Treatment Effects Maintained Over Six Years in Patients with Relapsing Remitting Multiple Sclerosis who Received Sanofi Genzyme's Lemtrada® (alemtuzumab) in Clinical Trials"
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