CAMBRIDGE, Mass., Sept. 9, 2020 /PRNewswire/ -- Sanofi Genzyme
today announced that new data from across the company's neurology
portfolio will be presented at MSVirtual2020, the 8th Joint
Americas Committee for Treatment and Research in Multiple Sclerosis
(ACTRIMS) - European Committee for Treatment and Research in
Multiple Sclerosis (ECTRIMS) Meeting from 11-13 September 2020.
The congress will feature new data relating to tolebrutinib
(SAR442168), an investigational oral,
brain-penetrant, selective small molecule inhibitor of Bruton's
tyrosine kinase (BTK). The poster, and a platform
presentation, extend previous findings on the role of BTK in
microglia and the potential of brain-penetrant BTK inhibitors to
block microglia-driven neuroinflammation implicated in MS disease
progression. Tolebrutinib is the proposed international
nonproprietary name for SAR442168.
In addition, several posters and platform presentations
highlight studies evaluating safety, efficacy and investigational
uses of approved therapies AUBAGIO® (teriflunomide) and
LEMTRADA® (alemtuzumab) reinforcing the consistent,
positive clinical profiles of these two treatment options.
Presentations at MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS
Meeting include:
Tolebrutinib
(SAR442168)
|
Decoding Bruton's
tyrosine kinase signaling in neuroinflammation
|
#P0311 (on-demand
e-poster)
Friday, 11 September
2:00 PM CEST / 8:00 AM ET
|
|
BTK signaling
regulates real-time microglial dynamics and prevents demyelination
in a novel in vivo model of antibody-mediated cortical
demyelination†
|
#YI01.06 (platform
presentation)
Saturday, 12
September
|
AUBAGIO®
(teriflunomide)
|
Teriflunomide
efficacy and safety in pediatric patients with relapsing forms of
MS: Interim analysis of open-label TERIKIDS trial
extension
|
#FC02.04 (platform
presentation)
Sunday, 13
September
7:36 – 7:48 PM CEST /
1:36-1:48 PM ET
|
Treatment
Satisfaction Across Age Groups in Patients Who Switched to
Teriflunomide: Analysis of the Real-world Teri-PRO Study
|
#P01065 (on-demand
e-poster)
Friday, 11 September
2:00 PM CEST / 8:00 AM ET
|
Effect of
Teriflunomide on Epstein-Barr Virus Shedding in Relapsing-Remitting
Multiple Sclerosis Patients: Outcomes From a Real-world Cohort
Study
|
#P0326 (on-demand
e-poster)
Friday, 11
September
2:00 PM CEST / 8:00 AM ET
|
Effect of
teriflunomide on MRI lesion activity across age groups in patients
with relapsing multiple sclerosis from the TEMSO study
|
#P0203 (on-demand
e-poster)
Friday, 11 September
2:00 PM CEST / 8:00 AM ET
|
LEMTRADA®
(alemtuzumab)
|
Alemtuzumab slowed
brain atrophy over 6 years in patients without relapse and MRI
disease activity: post hoc analysis of the pooled CARE-MS
studies
|
#P0024 (on-demand
e-poster)
Friday, 11 September
2:00 PM CEST / 8:00 AM ET
|
Safety of Alemtuzumab
Over 9 Years in Patients With Non-MS Autoimmunity
|
#FC02.01 (platform
presentation)
Sunday, 13
September
7:00 – 7:12 PM CEST /
1:00-1:12 PM ET
|
Outcomes in
Alemtuzumab-Treated Patients With Thyroid Adverse Events: 6-Year
Pooled CARE-MS Data
|
#P0128 (on-demand
e-poster)
Friday, 11
September
2:00 PM CEST / 8:00 AM ET
|
† In vivo studies were performed with the tool
compound PRN2675, the in vitro microglia gene signature study
(#P0311) was performed with SAR442168
About tolebrutinib (SAR442168)
Tolebrutinib is an
investigational, oral, brain-penetrant, selective small-molecule
inhibitor of BTK. Tolebrutinib has shown BTK binding as well as
cerebrospinal fluid exposure in Phase 1 studies. Sanofi obtained
global rights to develop and commercialize tolebrutinib under a
license agreement with Principia Biopharma, Inc. For more
information on tolebrutinib clinical trials, please visit
www.clinicaltrials.gov and search for "SAR442168". Tolebrutinib is currently under
clinical development, and its safety and efficacy have not been
reviewed by any regulatory authority.
AUBAGIO (teriflunomide) IMPORTANT SAFETY INFORMATION
AND INDICATION FOR U.S. PATIENTS
AUBAGIO® (teriflunomide) is a prescription
medicine used to treat relapsing forms of multiple sclerosis (MS),
to include clinically isolated syndrome, relapsing-remitting
disease, and active secondary progressive disease, in adults.
IMPORTANT SAFETY INFORMATION
DO NOT TAKE AUBAGIO IF YOU:
- Have severe liver problems. AUBAGIO may cause serious liver
problems, which can be life-threatening. Your risk may be
higher if you take other medicines that affect your liver. Your
healthcare provider should do blood tests to check your liver
within 6 months before you start AUBAGIO and monthly for 6 months
after starting AUBAGIO. Tell your healthcare provider right away if
you develop any of these symptoms of liver problems: nausea,
vomiting, stomach pain, loss of appetite, tiredness, yellowing of
your skin or whites of your eyes, or dark urine.
- Are pregnant. AUBAGIO may harm an unborn baby. You
should have a pregnancy test before starting AUBAGIO. After
stopping AUBAGIO, continue to use effective birth control until you
have made sure your blood levels of AUBAGIO are lowered. If you
become pregnant while taking AUBAGIO or within 2 years after
stopping, tell your healthcare provider right away and enroll in
the AUBAGIO Pregnancy Registry at 1–800–745–4447, option 2.
- Are of childbearing potential and not using effective birth
control.
It is not known if AUBAGIO passes into breast
milk. Your healthcare provider can help you decide if you
should take AUBAGIO or breastfeed — you should not do both at the
same time.
If you are a man whose partner plans to become
pregnant, you should stop taking AUBAGIO and talk with
your healthcare provider about reducing the levels of AUBAGIO in
your blood. If your partner does not plan to become pregnant, use
effective birth control while taking AUBAGIO.
- Have had an allergic reaction to AUBAGIO or a medicine
called leflunomide.
- Take a medicine called leflunomide for rheumatoid
arthritis.
AUBAGIO may stay in your blood for up to 2 years after you
stop taking it. Your healthcare provider can prescribe a
medicine that can remove AUBAGIO from your blood quickly.
Before taking AUBAGIO, talk with your healthcare provider if
you have: liver or kidney problems; a fever or infection,
or if you are unable to fight infections; numbness or tingling in
your hands or feet that is different from your MS symptoms;
diabetes; serious skin problems when taking other medicines;
breathing problems; or high blood pressure. Your healthcare
provider will check your blood cell count and TB test before you
start AUBAGIO. Talk with your healthcare provider if you take or
are planning to take other medicines (especially medicines for
treating cancer or controlling your immune system), vitamins or
herbal supplements.
AUBAGIO may cause serious side effects,
including: reduced white blood cell count — this may cause
you to have more infections; numbness or tingling in your hands or
feet that is different from your MS symptoms; allergic reactions,
including serious skin problems; breathing problems (new or
worsening); and high blood pressure. Patients with low white blood
cell count should not receive certain vaccinations during AUBAGIO
treatment and 6 months after.
Tell your doctor if you have any side effect that bothers you or
does not go away.
The most common side effects when taking AUBAGIO
include: headache; diarrhea; nausea; hair thinning or
loss; and abnormal liver test results. These are not all
the side effects of AUBAGIO. Tell your healthcare provider about
any side effect that bothers you.
Consult your healthcare provider if you have questions about
your health or any medications you may be taking, including
AUBAGIO.
Please click here for full Prescribing
Information, including boxed WARNING
and Medication Guide.
LEMTRADA (alemtuzumab) IMPORTANT SAFETY INFORMATION AND
INDICATION FOR U.S. PATIENTS
LEMTRADA is a prescription medicine used to treat relapsing
forms of multiple sclerosis (MS), to include relapsing-remitting
disease and active secondary progressive disease, in adults. Since
treatment with LEMTRADA can increase your risk of getting certain
conditions and diseases, LEMTRADA is generally prescribed for
people who have tried 2 or more MS medicines that have not worked
well enough. LEMTRADA is not recommended for use in patients with
clinically isolated syndrome (CIS). It is not known if LEMTRADA is
safe and effective for use in children under 17 years of age.
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 thrombocytopenic purpura (ITP), a condition of reduced
platelet counts in your blood that can cause severe bleeding that
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; coughing up
blood; 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, if not treated, can 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: swelling of your legs or feet; blood in the
urine (red or tea–colored urine); decrease in urine; fatigue;
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 if they happen.
Stroke and tears in your arteries that supply blood to your
brain (carotid and vertebral arteries): Some people have
had serious and sometimes deadly strokes and tears in their carotid
or vertebral arteries within 3 days of receiving LEMTRADA. Get help
right away if you have any of the following symptoms that may be
signs of a stroke or tears in your carotid or vertebral
arteries:
- drooping of parts of your face
- weakness on one side
- sudden severe headache
- difficulty with speech
- neck pain
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.
Do not receive LEMTRADA if you are infected with
human immunodeficiency virus (HIV).
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
- fast heartbeat
- eye swelling
- nervousness
- 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
Inflammation of the liver: Call your healthcare
provider right away if you have symptoms such as unexplained
nausea, stomach pain, tiredness, loss of appetite, yellowing of
skin or whites of eyes, or bleeding or bruising more easily than
normal.
Hemophagocytic lymphohistiocytosis: LEMTRADA may
increase the risk of overactivity of the immune system that can be
fatal if not diagnosed and treated early. If you experience
symptoms such as fever, swollen glands, or skin rash, contact your
healthcare provider right away.
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:
- listeria. People who receive LEMTRADA have an increased
chance of getting a bacterial infection called listeria, which can
lead to significant complications or death. Avoid foods that may be
a source of listeria or make sure foods are heated well.
- herpes viral infections. Some people taking LEMTRADA
have an increased chance of getting herpes viral infections. Take
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.
Progressive multifocal leukoencephalopathy (PML): A
rare brain infection that usually leads to death or severe
disability has been reported with LEMTRADA. Symptoms of PML get
worse over days to weeks. It is important that you call your doctor
right away if you have any new or worsening medical problems that
have lasted several days, including problems with:
- thinking
- eyesight
- strength
- balance
- weakness on 1 side of your body
- using your arms or legs
Inflammation of the gallbladder without gallstones
(acalculous cholecystitis): LEMTRADA may increase your
chance of getting inflammation of the gallbladder without
gallstones, a serious medical condition that can be
life-threatening. Call your healthcare provider right away if you
have any of the following symptoms:
- stomach pain or discomfort
- fever
- nausea or vomiting
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:
- have bleeding, thyroid, or kidney problems
- have a recent history of infection
- are taking a medicine called Campath®
(alemtuzumab)
- 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.
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 may report side effects to the FDA at
1-800-FDA-1088.
Please see full Prescribing
Information/Medication
Guide, including serious side effects.
About Sanofi
Sanofi is dedicated to
supporting people through their health challenges. We are a global
biopharmaceutical company focused on human health. We prevent
illness with vaccines, provide innovative treatments to fight pain
and ease suffering. We stand by the few who suffer from rare
diseases and the millions with long-term chronic conditions.
With more than 100,000 people
in 100 countries, Sanofi is transforming scientific innovation into
healthcare solutions around the globe.
Sanofi, Empowering
Life
|
Sanofi Media Relations Contact Sally Bain
Tel.: +1 (781) 264-1091
sally.bain@sanofi.com
|
Sanofi
Investor Relations Contacts Paris Eva Schaefer-Jansen
Arnaud Delepine Yvonne
Naughton
Sanofi Investor
Relations Contacts North America Felix
Lauscher Fara
Berkowitz Suzanne
Greco
IR main
line: Tel.: +33 (0)1 53 77 45
45
ir@sanofi.com
|
Sanofi
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|
Source: Sanofi (EURONEXT: SAN) (NASDAQ: SNY)
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