Sanofi Genzyme continues research to improve the lives of patients with multiple sclerosis, with new data presented at MSVirtual2020
- New data on investigational brain-penetrant BTK inhibitor tolebrutinib (SAR442168) further support its potential in modulating disabling inflammatory processes within the central nervous system
- Presentations provide deeper understanding of Sanofi Genzyme's current MS therapies and promising pipeline
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:
Decoding Bruton's tyrosine kinase signaling in neuroinflammation
#P0311 (on-demand e-poster)
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
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)
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
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)
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)
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
† 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.
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
- fast, slow, or irregular heartbeat
- chest pain
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
- unexplained weight gain
- feeling cold
- worsening tiredness
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:
- 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:
- 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
- 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
- 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:
- thyroid problems
- swelling of your nose and throat
- urinary tract infection
- feeling tired
- trouble sleeping
- upper respiratory infection
- herpes viral infection
- fungal infection
- joint pain
- pain in your arms or legs
- back pain
- sinus infection
- mouth pain or sore throat
- tingling sensation
- stomach pain
- sudden redness in face, neck, or chest
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.
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