New long-term efficacy and safety data
contribute to the understanding of potential clinical effects of
Aubagio® (teriflunomide) and Lemtrada®
(alemtuzumab)
Additional presentations on Genzyme’s
research and development programs reinforce the company’s
commitment to advancing the field of MS
Genzyme, a Sanofi company, announced today that new
investigational data on its marketed treatments, Aubagio®
(teriflunomide) and Lemtrada® (alemtuzumab), as well as data
from the company’s MS pipeline, will be presented during the 31st
Congress of the European Committee for Treatment and Research in
Multiple Sclerosis (ECTRIMS). The meeting, to be held in Barcelona,
Spain, October 7-10th, will feature more than 50 platform and
poster presentations of investigational data from across Genzyme’s
MS franchise.
In addition to its marketed therapies, Genzyme has an MS R&D
pipeline seeking to address unmet needs for relapsing and
progressive forms of MS through research in selective
immunomodulation, neuroprotection and remyelination.
The list of Genzyme-sponsored data presentations including the
company’s Satellite Symposium at ECTRIMS is as follows. Additional
investigator-sponsored data will also be presented.
Aubagio:
- Reduced risk of disability progression
in patients with MS treated with early vs delayed teriflunomide 14
mg (P555, Poster Session I; October 8; 3:45 – 5:00 p.m. CEST)
- Teriflunomide efficacy on annualized
relapse rate and expanded disability status scores: 2.5-year
follow-up in the TOWER extension study in patients with relapsing
MS (P1099, Poster Session I; October 8; 3:45 – 5:00 p.m. CEST)
- Teriflunomide efficacy in subsets of
patients with relapsing MS: Results from TEMSO and TOWER studies
(P1048, Poster Session I; October 8; 3:45 – 5:00 p.m. CEST)
- Teriflunomide safety in subsets of
patients with relapsing MS: Results from TEMSO and TOWER studies
(P1057, Poster Session I; October 8; 3:45 – 5:00 p.m. CEST)
- Effect of teriflunomide on relapses
associated with disability worsening: Results from TEMSO and TOWER
studies (P1031, Poster Session I; October 8; 3:45 – 5:00 p.m. CEST
)
- Efficacy of teriflunomide treatment in
achieving no evidence of disease activity over a period of 6 months
to 2 years in the TEMSO study (P1037, Poster Session I; October 8;
3:45 – 5:00 p.m. CEST)
- Predicting treatment response to
teriflunomide in the TEMSO study using the modified RIO score
(P1131, Poster Session I; October 8; 3:45 – 5:00 p.m. CEST)
- Efficacy of teriflunomide in MS
patients with a primary presentation of optic neuritis: a subgroup
analysis from the Phase III TOPIC study (P1042, Poster Session I;
October 8; 3:45 – 5:00 p.m. CEST)
- Biodistribution of teriflunomide in
naïve rats vs. rats with experimental autoimmune encephalomyelitis
(P354, Poster Session I; October 8; 3:45 – 5:00 p.m. CEST)
- Cost-effectiveness of first-line
disease-modifying treatments for relapsing remitting MS (P660,
Poster Session I; October 8; 3:45 – 5:00 p.m. CEST)
- Treatment satisfaction with injectable
disease-modifying therapy in patients with isolated demyelinating
syndrome or relapsing-remitting MS (P594, Poster Session I; October
8; 3:45 – 5:00 p.m. CEST)
- Teriflunomide mechanism of action:
Linking species’ sensitivities to pregnancy outcomes (P1033, Poster
Session I; October 8; 3:45 – 5:00 p.m. CEST)
- Exploring the clinical course of hair
thinning associated with teriflunomide: An update to the
teriflunomide real-world case series (P1113, Poster Session I;
October 8; 3:45 – 5:00 p.m. CEST)
- Characterizing the impact of
teriflunomide on adaptive immune cell substrates, repertoire and
function in patients with relapsing-remitting MS: TERI-DYNAMIC
(P1044, Poster Session I; October 8; 3:45 – 5:00 p.m. CEST )
- Improvements in patient-reported
outcomes with teriflunomide: Week 24 interim results from the US
cohort of the Teri-PRO Phase IV study (P562, Poster Session I;
October 8; 3:45 – 5:00 p.m. CEST)
- Efficacy of teriflunomide treatment in
achieving no evidence of disease activity (NEDA) in the TEMSO
long-term extension study (P1047, Poster Session II; October 9;
3:30 – 5:00 p.m. CEST)
- Safety and efficacy of transitioning to
teriflunomide in patients switching from other disease-modifying
therapies, including natalizumab (P1039, Poster Session II; October
9; 3:30 – 5:00 p.m. CEST)
- Long-term safety of teriflunomide:
2.5-year follow-up in the TOWER extension study in patients with
relapsing multiple sclerosis (EP1460, Poster Session II; October 9;
3:30 – 5:00 p.m. CEST)
- Teriflunomide slows brain volume loss
in relapsing MS: a SIENA analysis of the TEMSO MRI dataset
(Parallel Session 13, Late Breaking News, Oral Platform
Presentation; October 10; 9:03 – 9:14 a.m. CEST)
Lemtrada:
- Improvement in relapse outcomes
following switch from subcutaneous interferon beta-1a to
alemtuzumab: CARE-MS II extension study (P639, Poster Session I;
October 8; 3:45 – 5:00 p.m. CEST)
- No evidence of disease activity
achieved in patients with active relapsing-remitting MS who
switched to alemtuzumab from subcutaneous interferon beta-1a:
CARE-MS I and II extension (P637, Poster Session I; October 8; 3:45
– 5:00 p.m. CEST)
- Detection and management of immune
thrombocytopenia in alemtuzumab-treated patients in the MS clinical
development program (P590, Poster Session I; October 8; 3:45 – 5:00
p.m. CEST)
- Durable efficacy of alemtuzumab on
clinical outcomes over 5 years in CARE-MS II with most patients
free from treatment for 4 years (P1102, Poster Session II; October
9; 3:30 – 5:00 p.m. CEST)
- Alemtuzumab demonstrates durable
reduction of MRI activity over 5 years in CARE-MS I with the
majority of patients treatment-free for 4 years (P1100, Poster
Session II; October 9; 3:30 – 5:00 p.m. CEST)
- Alemtuzumab demonstrates durable
reduction of MRI activity over 5 years in CARE-MS II with most
patients free from treatment for 4 years (P1103, Poster Session II;
October 9; 3:30 – 5:00 p.m. CEST)
- Durable improvement in expanded
disability status scale functional systems scores over 4 years with
alemtuzumab despite a majority of patients not receiving treatment
since year 1 (P1104, Poster Session II; October 9; 3:30 – 5:00 p.m.
CEST)
- Sustained reduction in disability with
alemtuzumab is associated with durable quality-of-life improvement
on SF-36 over 4 years in CARE-MS II patients with RRMS though most
were treatment-free after Year 1 (P1152, Poster Session II; October
9; 3:30 – 5:00 p.m. CEST)
- Durable efficacy of alemtuzumab in
CARE-MS II patients with highly-active RRMS: 4-year outcomes
(P1106, Poster Session II; October 9; 3:30 – 5:00 p.m. CEST )
- Durable improvement in clinical
outcomes with alemtuzumab following switch from subcutaneous
interferon beta-1a in treatment-naïve patients with active RRMS:
3-year follow-up of the CARE-MS I extension study (P1096, Poster
Session II; October 9; 3:30 – 5:00 p.m. CEST)
- Durable improvement in clinical
outcomes with alemtuzumab following switch from subcutaneous
interferon beta-1a in patients with active RRMS: 3-year follow-up
of the CARE-MS II extension study (P1101, Poster Session II;
October 9; 3:30 – 5:00 p.m. CEST)
- Switching from subcutaneous interferon
beta-1a to alemtuzumab further decreases new lesion activity and
slows brain volume loss in treatment-naïve patients with active
RRMS: CARE-MS I extension study (P1088, Poster Session II; October
9; 3:30 – 5:00 p.m. CEST)
- Alemtuzumab improves disability
outcomes vs. subcutaneous interferon beta-1a in CARE-MS I and II
patients with active relapsing MS using the novel SAD-plus endpoint
(P1132, Poster Session II; October 9; 3:30 – 5:00 p.m. CEST)
- Pregnancy outcomes in patients with
active RRMS who received alemtuzumab in the clinical development
program (P1120, Poster Session II; October 9; 3:30 – 5:00 p.m.
CEST)
- Detection of thyroid malignancies in
alemtuzumab-treated patients in the MS clinical development program
(P1117, Poster Session II; October 9; 3:30 – 5:00 p.m. CEST)
- Quality-of-life improvements in
patients with active RRMS are not impacted by acute infections
after receiving alemtuzumab in CARE-MS II (P1188, Poster Session
II; October 9; 3:30 – 5:00 p.m. CEST)
- TREAT-MS: design and baseline
characteristics of a non-interventional study to establish
effectiveness, quality-of-life, cognition, health-related, and
work-capacity data on alemtuzumab in MS patients in Germany (P1145,
Poster Session II; October 9; 3:30 – 5:00 p.m. CEST)
- Patient characteristics and compliance
with alemtuzumab infusion schedule and premedication regimen:
EMERALD study (EP1468, E-Poster Session II; October 9; 3:30 – 5:00
p.m. CEST)
- Durable efficacy of alemtuzumab on
clinical outcomes over 5 years in treatment-naïve patients with
active RRMS with most patients not receiving treatment for 4 years:
CARE-MS I extension study (Platform Session 152: Free
Communications Platform Presentations; October 9; 9:15 – 10:15 a.m.
CEST)
- Alemtuzumab slows brain volume loss
over 5 years in patients with active RRMS with most patients not
receiving treatment for 4 years: CARE-MS I and II extension study
(Platform Session 151: Free Communications Platform Presentations;
October 9; 9:15 – 10:15 a.m. CEST)
MS Pipeline:
- Safety, tolerability and
pharmacodynamic characterization of vatelizumab, a monoclonal
antibody targeting very-late-antigen (VLA)-2: A randomized,
double-blind, placebo-controlled Phase I study (P1077, Poster
Session II; October 9; 3:30 – 5:00 p.m. CEST)
- Characterization of vatelizumab, a
novel antibody that binds VLA-2 (P1062, Poster Session II; October
9; 3:30 – 5:00 p.m. CEST)
- EMPIRE: A randomized,
placebo-controlled study assessing efficacy, safety and dose
response of vatelizumab in patients with RRMS (EP1458, Poster
Session II; October 9; 3:30 – 5:00 p.m. CEST)
- GZ402668, a next-generation anti-CD52
antibody, binds to a unique epitope on human CD52 and displays
decreased cytokine release (EP1448, E-Poster Session II; October 9;
3:30 – 5:00 p.m. CEST)
- Targeting innate immune cells as a
novel therapeutic approach for MS (P1069, Poster Session II;
October 9; 3:30 – 5:00 p.m. CEST)
Abstracts are available on the ECTRIMS website.
Genzyme Satellite Symposium“Preserving Brain and
Function; Evolution from T and B Cell Pathophysiology to
Treatment”Date: Thursday, October 8; 7:45 – 8:45 a.m.Location: Hall
A
Aubagio® (teriflunomide) U.S.
IndicationAubagio is indicated for the treatment of patients
with relapsing forms of multiple sclerosis.
Important Safety Information About Aubagio
WARNING: HEPATOTOXICITY AND RISK OF
TERATOGENICITYSevere liver injury including fatal liver
failure has been reported in patients treated with leflunomide,
which is indicated for rheumatoid arthritis. A similar risk would
be expected for teriflunomide because recommended doses of
teriflunomide and leflunomide result in a similar range of plasma
concentrations of teriflunomide. AUBAGIO is contraindicated in
patients with severe hepatic impairment and in patients taking
leflunomide. Concomitant use of AUBAGIO with other potentially
hepatotoxic drugs may increase the risk of severe liver injury.
Obtain transaminase and bilirubin levels within 6 months before
initiation of AUBAGIO therapy. Monitor ALT levels at least monthly
for 6 months after starting AUBAGIO. If drug induced liver injury
is suspected, discontinue AUBAGIO and start an accelerated
elimination procedure with cholestyramine or charcoal. Patients
with pre-existing liver disease may be at increased risk of
developing elevated serum transaminases when taking AUBAGIO. Based
on animal data, AUBAGIO may cause major birth defects if used
during pregnancy. Pregnancy must be excluded before starting
AUBAGIO. AUBAGIO is contraindicated in pregnant women or women of
childbearing potential who are not using reliable contraception.
Pregnancy must be avoided during AUBAGIO treatment or prior to the
completion of an accelerated elimination procedure after AUBAGIO
treatment.
Warnings and PrecautionsPatients with pre-existing acute
or chronic liver disease, or those with serum ALT >2 times the
upper limit of normal (ULN) before initiating treatment, should not
normally be treated with AUBAGIO. In clinical trials, if ALT
elevation was >3 times the ULN on 2 consecutive tests, patients
discontinued AUBAGIO and underwent accelerated elimination.
Consider additional monitoring if co-administering AUBAGIO with
other potentially hepatotoxic drugs; monitor patients who develop
symptoms suggestive of hepatic dysfunction (eg, unexplained nausea,
vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or
dark urine).
Before starting therapy, use of reliable contraception must be
confirmed, and the patient counseled on risks to the fetus.
Patients with delayed onset of menses or other reason to suspect
pregnancy should immediately see their physician for pregnancy
testing. Patients who become pregnant or wish to become pregnant
should discontinue treatment, followed by accelerated elimination
until plasma concentrations of <0.02 mcg/mL are verified, a
level expected to pose minimal risk to the fetus. Women who become
pregnant while taking AUBAGIO may enroll in the AUBAGIO pregnancy
registry by calling 1-800-745-4447, option 2. Teriflunomide is
eliminated slowly from the plasma—it takes an average of 8 months,
or up to 2 years, to reach plasma concentrations <0.02 mcg/mL.
Elimination may be accelerated by administration of cholestyramine
or charcoal, but this may cause disease activity to return in
patients who were responding to AUBAGIO.
Decreases in white blood cell counts, mainly of neutrophils and
lymphocytes, and platelets have been reported with AUBAGIO. Obtain
a complete blood cell count within 6 months before starting
treatment, with further monitoring based on signs and symptoms of
bone marrow suppression. AUBAGIO is not recommended for patients
with severe immunodeficiency, bone marrow disease, or severe
uncontrolled infections. Tuberculosis (TB) has been observed in
clinical studies of AUBAGIO. Before starting treatment, screen
patients for latent TB infection with a tuberculin test. Treatment
in patients with acute or chronic infections should not be started
until the infection(s) is resolved. Administration of live vaccines
is not recommended. The risk of malignancy, particularly
lymphoproliferative disorders, or infection may be increased with
the use of some medications with immunosuppressive potential,
including teriflunomide. Peripheral neuropathy, including
polyneuropathy and mononeuropathy, has been reported with AUBAGIO.
Age >60 years, concomitant neurotoxic medications, and diabetes
may increase the risk. If peripheral neuropathy is suspected,
consider discontinuing treatment and performing accelerated
elimination.
Interstitial lung disease and rare cases of Stevens-Johnson
syndrome and toxic epidermal necrolysis have been reported with
leflunomide; a similar risk would be expected for teriflunomide. If
a severe skin reaction develops with AUBAGIO, stop treatment and
use accelerated elimination.
Blood pressure increases and hypertension have occurred with
AUBAGIO. Measure blood pressure at treatment initiation and manage
any elevations during treatment.
Adverse Reactions: The most frequent adverse reactions
(≥10% and ≥2% greater than placebo) with AUBAGIO 7 mg and 14 mg and
placebo, respectively, were headache (18% and 16% vs 15%), ALT
increased (13% and 15% vs 9%), diarrhea (13% and 14% vs 8%),
alopecia (10% and 13% vs 5%), and nausea (8% and 11% vs 7%).
Drug Interactions: Monitor patients when teriflunomide is
coadministered with warfarin, or with drugs metabolized by CYP1A2,
CYP2C8, substrates of OAT3 transporters, substrates of BCRP, or
OATP1B1/1B3 transporters.
Use in Specific Populations: AUBAGIO is detected in human
semen. To minimize any possible fetal risk, men not wishing to
father a child and their female partners should use reliable
contraception. Men wishing to father a child should discontinue
therapy and undergo accelerated elimination, with verification of
plasma concentrations <0.02 mcg/mL. Nursing mothers should not
use AUBAGIO.
Please click here for full US Prescribing Information for
Aubagio, including Boxed WARNING.
About Aubagio® (teriflunomide)Aubagio is
approved in more than 50 countries, with additional marketing
applications under review by regulatory authorities globally. More
than 40,000 people have been treated with Aubagio worldwide.
Aubagio is an immunomodulator with anti-inflammatory properties.
Although the exact mechanism of action for Aubagio is not fully
understood, it may involve a reduction in the number of activated
lymphocytes in the central nervous system (CNS). Aubagio is
supported by one of the largest clinical programs of any MS
therapy, with more than 5,000 trial participants in 36
countries.
Lemtrada® (alemtuzumab) U.S. Indication
LEMTRADA is indicated 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.
CONTRAINDICATIONSLEMTRADA is contraindicated in patients
who are infected with Human Immunodeficiency Virus (HIV) because
LEMTRADA causes prolonged reductions of CD4+ lymphocyte counts.
Important Safety Information About Lemtrada for U.S.
Patients
WARNING: AUTOIMMUNITY, INFUSION REACTIONS, AND
MALIGNANCIES
LEMTRADA causes serious, sometimes fatal, autoimmune
conditions such as immune thrombocytopenia and anti-glomerular
basement membrane disease. Monitor complete blood counts with
differential, serum creatinine levels, and urinalysis with urine
cell counts at periodic intervals for 48 months after the last dose
of LEMTRADA.
LEMTRADA causes serious and life-threatening infusion
reactions. LEMTRADA must be administered in a setting with
appropriate equipment and personnel to manage anaphylaxis or
serious infusion reactions. Monitor patients for two hours after
each infusion. Make patients aware that serious infusion reactions
can also occur after the 2-hour monitoring period.
LEMTRADA may cause an increased risk of malignancies,
including thyroid cancer, melanoma, and lymphoproliferative
disorders. Perform baseline and yearly skin exams.
Because of the risk of autoimmunity, infusion reactions, and
malignancies, LEMTRADA is available only through restricted
distribution under a Risk Evaluation and Mitigation Strategy (REMS)
Program. Call 1-855-676-6326 to enroll in the LEMTRADA REMS
Program.
WARNINGS AND PRECAUTIONS
Autoimmunity: Treatment with LEMTRADA can result in the
formation of autoantibodies and increase the risk of serious
autoimmune mediated conditions, and may increase the risk of other
autoimmune conditions because of the broad range of autoantibody
formation. Obtain complete blood counts (CBC) with differential,
serum creatinine levels, and urinalysis with cell counts before
starting treatment and then at monthly intervals for 48 months
after the last dose of LEMTRADA, or longer, if clinically
indicated.
Infusion Reactions: LEMTRADA causes cytokine release
syndrome resulting in infusion reactions. In clinical studies, 92%
of LEMTRADA-treated patients experienced infusion reactions.
Serious reactions occurred in 3% of these patients and included
anaphylaxis in 2 patients (including anaphylactic shock),
angioedema, bronchospasm, hypotension, chest pain, bradycardia,
tachycardia (including atrial fibrillation), transient neurologic
symptoms, hypertension, headache, pyrexia, and rash. In some
patients, infusion reactions were reported more than 24 hours after
LEMTRADA infusion. Premedicate patients with corticosteroids
immediately prior to LEMTRADA infusion for the first 3 days of each
treatment course. Consider pretreatment with antihistamines and/or
antipyretics. Infusion reactions may occur despite
pretreatment.
Malignancies: Monitor for symptoms of thyroid cancer.
Because LEMTRADA is an immunommodulatory therapy, caution should be
exercised in initiating LEMTRADA in patients with pre-existing or
ongoing malignancies.
LEMTRADA REMS Program: Only prescribers, patients,
pharmacies and healthcare facilities certified and enrolled in the
REMS program can prescribe, receive, dispense or administer
LEMTRADA. Healthcare facilities must have on-site access to
equipment and personnel trained to manage infusion reactions
(including anaphylaxis and cardiac and respiratory
emergencies).
Immune thrombocytopenia (ITP) occurred in 2% of
LEMTRADA-treated patients in clinical studies in MS. One
LEMTRADA-treated patient developed ITP that went unrecognized prior
to the implementation of monthly monitoring requirements, and died
from an intracerebral hemorrhage. ITP has been diagnosed more than
3 years after the last LEMTRADA dose. If ITP is confirmed, promptly
initiate medical intervention.
Glomerular nephropathies occurred in 0.3% of
LEMTRADA-treated patients in MS clinical trials and have been
diagnosed up to 40 months after the last dose of LEMTRADA.
Anti-glomerular basement membrane (anti-GBM disease) can lead to
renal failure requiring dialysis and transplantation and has in
post-marketing cases of MS patients treated with alemtuzumab.
Anti-GBM disease can be life-threatening if untreated; early
detection and treatment may decrease the risk of poor outcomes.
Autoimmune thyroid disorders occurred in 34% of
LEMTRADA-treated patients in clinical studies. Newly diagnosed
thyroid disorders occurred throughout the uncontrolled clinical
study follow-up period, more than 7 years after the first LEMTRADA
dose. Serious thyroid events occurred in 2% of patients, including
cardiac and psychiatric events. In LEMTRADA-treated patients, 3%
underwent thyroidectomy. In patients with an ongoing thyroid
disorder, LEMTRADA should be administered only if the potential
benefit justifies the potential risks. Obtain thyroid function
tests prior to initiation of treatment and every 3 months until 48
months after the last infusion, or longer, if clinically indicated.
Thyroid disease poses special risks in women who are pregnant.
Autoimmune cytopenias occurred in LEMTRADA-treated MS
patients in clinical trials. One LEMTRADA-treated patient with
autoimmune pancytopenia died from sepsis. Prompt medical
intervention is indicated if a cytopenia is confirmed.
Infections occurred in 71% of LEMTRADA-treated patients
compared to 53% of patients treated with interferon beta-1a.
Serious infections occurred in 3% of patients treated with LEMTRADA
and 1% of patients treated with interferon beta-1a and included:
appendicitis, gastroenteritis, pneumonia, herpes zoster, and tooth
infection. Consider delaying LEMTRADA administration in patients
with active infection until the infection is fully controlled.
- Do not administer live viral vaccines
following a course of LEMTRADA, as patients may be at increased
risk of infection.
- Concomitant use of antineoplastic or
immunosuppressive therapies could increase the risk of
immunosuppression.
- Herpes viral infection developed in 16%
of LEMTRADA-treated patients compared to 3% of interferon beta-1a
patients. Administer antiviral prophylaxis for herpetic viral
infections starting on the first day of each treatment course and
continue for a minimum of two months following treatment with
LEMTRADA or until CD4+ lymphocyte count is ≥200 cells per
microliter, whichever occurs later.
- Cervical human papilloma virus (HPV)
infection occurred in 2% of LEMTRADA treated patients. Annual
screening is recommended for female patients.
- Active and latent tuberculosis cases
occurred in 0.3% of LEMTRADA-treated patients, most often in
endemic regions.
- Fungal infections, especially oral and
vaginal candidiasis, occurred in 12% of LEMTRADA-treated patients
compared to 3% of interferon beta-1a patients.
- Cases of listeria meningitis occurred
within 1 month of LEMTRADA dosing. Advise patients to avoid or
adequately heat foods that are potential sources for Listeria
monocytogenes.
- Before initiating LEMTRADA, consider
screening patients at high risk of Hepatitis B Virus (HBV) and
Hepatitis C Virus (HCV) infection. Carriers of HBV and/or HCV who
receive LEMTRADA may be at risk of irreversible liver damage
relative to a potential virus reactivation.
Pneumonitis, including hypersensitivity pneumonitis and
pneumonitis with fibrosis, occurred in 6 of 1217 (0.5%)
LEMTRADA-treated patients in clinical studies. Advise patients to
report symptoms of pneumonitis (e.g., shortness of breath, cough,
wheezing, chest pain or tightness, and hemoptysis).
Drug Products with Same Active Ingredient: LEMTRADA
contains the same active ingredient (alemtuzumab) found in
CAMPATH®. If LEMTRADA is considered for use in a patient who has
previously received CAMPATH, exercise increased vigilance for
additive and long-lasting effects on the immune system.
Adverse ReactionsIn clinical trials, the most common
adverse reactions (incidence ≥10% and >interferon beta-1a) with
LEMTRADA vs interferon beta-1a were: rash (53% vs 6%), headache
(52% vs 23%), pyrexia (29% vs 9%), nasopharyngitis (25% vs 19%),
nausea (21% vs 9%), urinary tract infection (19% vs 8%), fatigue
(18% vs 13%), insomnia (16% vs 15%), upper respiratory tract
infection (16% vs 13%), herpes viral infection (16% vs 3%),
urticaria (16% vs 2%), pruritus (14% vs 2%), thyroid gland
disorders (13% vs 3%), fungal infection (13% vs 4%), arthralgia
(12% vs 9%), pain in extremity (12% vs 9%), back pain (12% vs 8%),
diarrhea (12% vs 6%), sinusitis (11% vs 8%), oropharyngeal pain
(11% vs 5%), paresthesia (10% vs 8%), dizziness (10% vs 5%),
abdominal pain (10% vs 5%), flushing (10% vs 4%), and vomiting (10%
vs 3%).
Use in Specific PopulationsLEMTRADA should be used during
pregnancy only if the potential benefit justifies the potential
risk to the fetus. Autoantibodies may be transferred from the
mother to the fetus during pregnancy. Placental transfer of
anti-thyroid antibodies resulted in a case of neonatal Graves’
disease. Safety and effectiveness in pediatric patients less than
17 years of age have not been established. Use of LEMTRADA is not
recommended in pediatric patients due to the risks of autoimmunity
and infusion reactions, and because it may increase the risk of
malignancies.
Please click here for full US Prescribing Information for
Lemtrada, including Boxed WARNING.
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 worldwide 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 CompanyGenzyme 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®, Aubagio® and Lemtrada® are registered
trademarks of Genzyme Corporation. All rights reserved.
About SanofiSanofi, 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).
Sanofi Forward-Looking StatementsThis 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 policies 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, 2014. 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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version on businesswire.com: http://www.businesswire.com/news/home/20150923005629/en/
Genzyme Media RelationsErin Pascal, + 1
617-768-6864erin.pascal@genzyme.comorSanofi Investor
RelationsSébastien Martel, +33 (0) 1 53 77 45
45ir@sanofi.com
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