May 9, 2018 Columns by Cathy Chester The Agony of Decision-making when It’s Time to Switch MS Medications Iām agonizing over an important decision and it’s driving me crazy. Iām usually a quick decision-maker, but this one is tough. I have my analytical hat on, trying to look at my choices from a scientific standpoint. Unfortunately, my anxiety kicks in, and my hat…
April 5, 2018 News by Mary Chapman MS Path 2 Care Program Aims to Empower Patients to Be Active in Healthcare Journey In the first year after being diagnosed with multiple sclerosis (MS) inĀ 1997, Ann Borsellino basically withdrew from life, rarely even leaving her bedroom. Knowing little about the disease, she assumed its relapses would soon rob her of any control over her body. They didn’t, and now Borsellino is involved with…
March 23, 2018 Columns by Ed Tobias It Shouldn’t Be This Hard to Get Our MS Medications I got a phone call from my MS One to One nurse, Lynn, today. One to One is the patient support service provided by Sanofi Genzyme for patients on the biotech company’s MS disease-modifying therapies (DMTs) Lemtrada (alemtuzumab) and Aubagio (teriflunomide). Lynn called to ensure that all…
February 27, 2018 Columns by Ed Tobias What’s Hot and What’s Not Among MS Therapies? The newest kids on the MS block, disease-modifying therapies (DMT) such as Genentech’s Ocrevus (ocrelizumab) and Sanofi Genzyme’s Lemtrada (alemtuzumab), are attracting a lot of interest these days. But, some DMTs that have been around for more than two decades are still being prescribed by a lot of neurologists.
February 8, 2018 Columns by Tamara Sellman The MS Alphabet: Plaquenil, PML, Prevalence, and Other ‘P’ Words (Part 6 of 7) Editorās note: Tamara Sellman continues her occasional series on the “MS alphabet” with this column referencing terms starting with the letter “P.” This post comes sixth in a series of seven. Symptoms of MS Progressive multifocal leukoencephalopathy (PML) Though progressive multifocal leukoencephalopathy (PML) isnāt an actual symptom of MS,…
October 30, 2017 News by Patricia Silva, PhD #MSParis2017 ā Aubagio Can Help Slow Progression to an MS Diagnosis, Researcher Says Aubagio (teriflunomide)Ā can help to delay first clinical signs of multiple sclerosis (MS) from progressing to a definite diagnosis in a person, and treatment should likely begin as soon as that first episode is confirmed,Ā Robert Zivadinov, a professor of neurology and director of the Buffalo Neuroimaging Analysis Center, said…
October 27, 2017 News by Patricia Silva, PhD #MSParis2017 – MS Therapy Aubagio Does Not Appear to Cause Birth Defects, Study Reports Sanofi Genzyme’sĀ multiple sclerosis therapyĀ Aubagio (teriflunomide) does not appear to cause birth defects in humans as it does in laboratory animals, researchers concluded after studying more than 100 pregnant women with MS. Their research indicated that birth-defectĀ findings in rats and rabbits do not translate to humans. The team presented its…
October 23, 2017 News by Patricia Silva, PhD #MSParis2017 – Sanofi to Present Long-term Data on Lemtrada and Aubagio Use New data on how Lemtrada and Aubagio perform in a real-world setting will be the focus of Sanofi Genzyme when the company showcases its research at the upcoming 7th Joint ECTRIMS-ACTRIMS Meeting in Paris this week. Researchers will also share information about the safety of a new investigational therapy, GLD52 (GZ402668), currently in a Phase 1 safety study. The TOPAZ study is one of the main data sources for the upcoming presentations. The study, which follows relapsing MS patients who participated in the CARE MS-I and CARE MS-II extension study , is a rich source of information on long-term outcomes. Researchers will share various aspects of disease outcomes and magnetic resonance imaging (MRI) data from patients followed up to seven years, with some presentations focusing solely on those who switched from treatment with interferon beta-1a. Among the Lemtrada highlights are findings demonstrating that Lemtrada does not appear to trigger birth defects. Another presentation compared Lemtrada to Genentechās Ocrevus using a model that evaluated both the cost and effectiveness of the two drugs. The analysis suggests that Lemtrada more effectively treated relapsing MS and was also linked to lower costs over a 20-year period. Aubagio studies also focused on long-term patient data, including in people with progressive forms of relapsing MS. Data from the Phase 3 TEMSO , TOWER , and the TEMSO extension showed that Aubagio stabilized disability progression in these patients over nearly a decade. Other presentations homed in on Aubagioās ability to slow brain tissue loss and improve cognitive outcomes. Finally, Sanofi Genzyme shared initial data on its investigational antibody GLD52. The treatment is an updated form of Lemtrada, which scientists believe gives rise to fewer and milder infusion-related reactions. Data from the Phase 1 study , so far indicated that this might indeed be the case, as no severe reactions occurred in the 44 progressive MS patients in the trial. For a complete list of Sanofi Genzyme's presentations at the meeting, visit this link.
October 16, 2017 News by Patricia Silva, PhD Multiple Sclerosis Therapy Aubagio May Cause Nail Loss, Researchers Report Aubagio (teriflunomide) may lead to reversible nail loss, researchers at Italy'sĀ University of BolognaĀ reported after reviewing the case of a 55-year-old woman with relapsing-remitting multiple sclerosis. They described what happened to a patient who was referred to an MS clinic after experiencing acute optic neuritis ā or inflammation of the optic nerve ā three months earlier.Ā Their report, āNail loss after teriflunomide treatment: A new potential adverse event,āĀ was published in the journal Multiple Sclerosis and Related Disorders. Doctors had been treating the woman with intravenous methylprednisolone. Physicians had judged her slightly disabled, with an Expanded Disability Status Scale (EDSS) score of 3, but had not diagnosed her with MS. When she was diagnosed a few months later, she began receiving interferon beta-1a. It did not work, so doctors switched her to Sanofi Genzyme'sĀ Aubagio. At first, she tolerated the treatment well, having only slight nausea after taking the medication. Physicians did not detect signs of liver toxicity or high blood pressure, which are relatively common side effects of Aubagio. Roughly three months after starting the medication, however, the woman began having more trouble walking problems and had mild hair loss. Two and a half months later, she said her nails had started falling out in the past month. When doctors examined her, she had lost two nails, while others appeared to have stopped growing. They were thinner than normal and some had detached from the nail bed. In addition, her hair loss continued. She had not started using other drugs, new cosmetics, or changed her diet. A dermatologist excluded the possibility that the condition was the result of fungus, psoriasis, or other conditions that could cause nails to fall off. Because doctors suspected that Aubagio could be the cause of the nail loss, they recommended that she stopped taking it. The patient switched to Biogen'sĀ Tecfidera (dimethyl fumarate) after a couple of weeks, and her nails started to grow again. This supported doctorsā idea that Aubagio had caused the nail loss, and that it was reversible. Nail growth is similar to that of hair, researchers said. The patientās reaction could be an unusual version of the same process that makes people lose their hair when taking Aubagio, they said. Since nail loss is not described as a side effect of Aubagio on the medication's label, researchers urged MS specialists to consider the possibility if they see patients with the problem. Ā
August 8, 2017 News by Patricia Silva, PhD TG Therapeutics, FDA Agree on Phase 3 Program to Evaluate Relapsing MS Therapy TG-1101 TG TherapeuticsĀ and the U.S. Food and Drug Administration (FDA) have agreed on a special protocol assessment for a Phase 3 trial program evaluating TG-1101 (ublituximab)Ā to potentially treatĀ relapsing forms of multiple sclerosis (MS). A special protocol assessment (SPA) is a procedure by which the agency officially evaluates the…
April 26, 2017 News by Joana Fernandes, PhD Sanofi Genzyme to Present New Data on MS Treatments Lemtrada and Aubagio Sanofi Genzyme will present new results on follow-up studies of its products Lemtrada (alemtuzumab) and Aubagio (teriflunomide), both of which have been approved for the treatment of relapsing-remitting multiple sclerosis (RRMS). The new data will be presented at the American Academy of Neurology (AAN) Annual MeetingĀ taking…
April 19, 2017 News by Patricia Inacio, PhD Sanofi Genzyme to Discuss Three Multiple Sclerosis Therapies at Boston Event Sanofi GenzymeĀ will discuss three of its multiple sclerosis therapies at theĀ American Academy of Neurology annual meetingĀ in Boston, April 22-28. The presentations will cover two approved treatments for relapsing MS ā LemtradaĀ (alemtuzumab) and AubagioĀ (teriflunomide) ā and one that has been in a Phase 1 clinical…
November 8, 2016 News by Patricia Silva, PhD Plans by 4 Countries to Subsidize Cost of Newer MS Drugs May Weight on US A cost-effectiveness analysis of reimbursement recommendationsĀ for four relatively new multiple sclerosis (MS) treatments made by agencies in four countries ā Australia, Canada, Sweden, and the U.K. ā found overwhelming support (88 percent) for either full or restricted reimbursement for each therapy. The analysis, performed by theĀ Decision Resources Group, is…
September 20, 2016 News by Patricia Silva, PhD #ECTRIMS2016 – Sanofi Releases Patients’ Views of Aubagio as Effective Treatment for Relapsing MS Sanofi GenzymeĀ presented positive results from itsĀ Phase 4 study into patient-reported assessments ofĀ Aubagio (teriflunomide), an approved oral treatmentĀ for relapsing forms of multiple sclerosis (RMS). Real-world patient responses were reported at the 32ndĀ Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), recentlyĀ held in London. The clinical…
July 6, 2016 News by InĆŖs Martins, PhD ICER Draft Report Evaluating Therapies for RRMS Now Open for Public Comment TheĀ Institute of Clinical and Economic Review (ICER)Ā released the early draft of a paper intended toĀ informĀ a future report evaluating the effectiveness and value of disease-modifying therapies for relapsing-remitting multiple sclerosis (RRMS). The paper, called aĀ draft scopingĀ document, is titled “Disease Modifying Therapies for Relapsing-Remitting Multiple Sclerosis: Effectiveness and…
June 13, 2016 News by Patricia Silva, PhD Genmab to Begin Phase 3 Trials of Ofatumumab to Treat Relapsing Multiple Sclerosis GenmabĀ announced plans to soon begin a Phase 3Ā clinical trial program assessing the subcutaneous formulation of ofatumumabĀ as a potential treatment forĀ relapsing multiple sclerosis (MS). The company, workingĀ in collaboration with its partnerĀ Novartis, will begin enrolling patients in September in trials that willĀ evaluate the efficacy and safety of ofatumumab compared…
April 18, 2016 News by Patricia Silva, PhD Sanofi Genzyme Presenting New Data on Its Approved and Investigational Multiple Sclerosis Treatments at AAN Sanofi GenzymeĀ will present new data onĀ itsĀ approved multiple sclerosis (MS) treatments āĀ LemtradaĀ (alemtuzumab) and AubagioĀ (teriflunomide) ā at the 68thĀ annual meeting of the American Academy of Neurology (AAN), taking place in Vancouver, Canada, through April 21, as well asĀ data on investigational therapies in its pipeline. In total, the meeting…
April 1, 2016 News by Malika Ammam, PhD Study Finds Aubagio Well-tolerated and Efficient in Long-term MS Treatment Researchers at the University of Texas Health Science Center at Houston, in collaboration with various institutions from north America and Europe, found that teriflunomide (Aubagio) is well-tolerated and efficient for long-term treatment of multiple sclerosis (MS). The findings, entitled āLong-term safety and efficacy of teriflunomide,ā were…
March 21, 2016 News by Patricia Silva, PhD CONy16: Sanofi Genzyme Symposium on MS Therapies Targeting T and B Cells; Exclusive Interview with Lead Researcher Sanofi Genzyme,Ā one of the companies participatingĀ in the four-dayĀ 10th World Congress on Controversies in Neurology (CONy) in Lisbon, Portugal, that concludedĀ on March 20, 2016, supported several symposiums focused on multiple sclerosis (MS) ā including one on B-cell and T-cell therapies. For over a decade, Sanofi Genzyme has workedĀ to developĀ effective therapies…
March 4, 2016 News by Patricia Silva, PhD In ‘Take Action on MS,’ a New Web Series, Actress Madeleine Stowe Tackles Topics of Import to RRMS Patients Genzyme, a specialty care unit of Sanofi, announced thatĀ TV and film actress Madeleine Stowe willĀ hostĀ its new online series, “Take Action on MS,”Ā focusing onĀ people living with relapsing multiple sclerosis (MS). Stowe, whose father had MS, works with Genzyme to educate people across the U.S. about daily life with the…
December 14, 2015 News by Patricia Silva, PhD 2 New Treatments for Relapsing-Remitting MS Now Available in New Zealand The Multiple Sclerosis Society of New Zealand (MSNZ)Ā announced thatĀ PHARMAC has agreed with its requestĀ toĀ finance two novel first-in-line therapies for relapsing-remitting forms of multiple sclerosis (MS), making them accessible to patients there. PHARMAC recently agreed to fund theĀ two treatments, teriflunomide (Aubagio), supplied by Sanofi-Aventis NZ, and dimethyl fumarate (Tecfidera),…
October 13, 2015 News by Patricia Silva, PhD Insights into Promising MS Therapies at Late Breaking News Session, ECTRIMS 2015 A session titled āLate Breaking Newsā was featured at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), Oct. 7-10, 2015, in Barcelona, Spain. At this session, Prof. Xavier Montalban from the Hospital Vall d’Hebron University in Barcelona presented data on the promising Genentech/Roche…
October 8, 2015 News by Patricia Silva, PhD Aubagio (Teriflunomide) Slows Brain Atrophy in Patients with Relapsing Multiple Sclerosis GenzymeĀ recently announced results from magnetic resonance imaging (MRI) analysis of participants in the Phase III TEMSO clinical trial showing that AubagioĀ®Ā (teriflunomide) was able to slow the loss of brain volume (or atrophy) versus a placebo over two years in patients with relapsing multiple sclerosis (RMS). Brain volume loss (BVL)…
June 26, 2015 News by Charles Moore Health Canada Non-Insured Health Benefits Program Approves AUBAGIO for Relapsing Remitting Multiple Sclerosis Genzyme Canada has announced that Health Canada has approved its 14 mg dose of AUBAGIO as an expedited exception benefit product through the federal health regulator’s Non-Insured Health Benefits (NIHB) Program for eligible First Nations people and Inuit as a first-line oral tablet therapy for relapsing remitting multiple sclerosis (RRMS).
May 26, 2015 News by Patricia Silva, PhD AUBAGIO Included in Prince Edward Island Pharmacare Canadian province Prince Edward Island (PEI) has approved the inclusion of Aubagio (teriflunomide) 14 mg in the PEI Pharmacare’s provincial drug formulary. This means that the drug developed and commercialized byĀ Genzyme is now financially supported by the state as aĀ first-line oral tablet to treat patients who…
January 7, 2015 News by Charles Moore Nova Scotia First Of Canada’s Atlantic Provinces To Fund Aubagio Treatment For Relapsing Remitting Multiple Sclerosis Canada has one of the world’s highest Multiple Sclerosis (MS) prevalence rates. Some 100,000 Canadians live with the disease, and three people are newly diagnosed each day. Most people are diagnosed with relapsing MS in their twenties and thirties, and MS is the most common neurological disease affecting young adults…
December 26, 2014 News by Patricia Silva, PhD British Columbia Agrees To fund AUBAGIO RRMS Therapy British Columbia’sĀ PharmaCare drug program has announced thatĀ it will fundĀ AUBAGIO, a therapy developed byĀ GenzymeĀ for the treatment of multiple sclerosis.Ā AUBAGIO (teriflunomide) 14 mg has been officially added toĀ PharmaCare’s provincial formulary as a first-line oral agent for patients suffering from relapsing remitting multiple sclerosis (RRMS). As…
December 2, 2014 News by Patricia Silva, PhD Aubagio for Relapsing-Remitting MS Now Funded in Alberta Genzyme, a Sanofi company with over 30 years of dedication to researching and developing novel treatments for rare and orphan diseases, has just announced the Alberta Drug Program has finally decided to include AubagioĀ® (teriflunomide) 14mg in the provincial drug formulary, indicated for the first-line…
November 25, 2014 News by Charles Moore Province Of Ontario Funds Genzyme’s AUBAGIO For Relapsing Remitting Multiple Sclerosis With 100,000 Canadians living with Multiple Sclerosis (MS), and three people newly diagnosed every day, Canada has one of the highest prevalence rates for the disease in the world. Most people are diagnosed with relapsing MS in their twenties and thirties, and MS is the most common neurological disease affecting…
October 27, 2014 News by Patricia Silva, PhD Positive Data from Two Key MS Trials Added To Aubagio’s U.S. Label The Food and Drug Administration (FDA) recently accepted the results from Genzyme’s TOWER and TOPIC Ā clinical trials,Ā which assessed the safety and efficacy of oral, once-daily AubagioĀ® (teriflunomide) for Multiple Sclerosis, and will add the positive data to the productās U.S. label. Genzyme is a leader in the development…