New results from a Phase 2 trial evaluating TG Therapeutics’ ublituximab continue to support the therapy’s efficacy in treating relapsing forms of multiple sclerosis (MS). This investigative infusion therapy is now moving into a Phase 3 study. Treatment with 450 mg of ublituximab delivered intravenously in a rapid fashion…

I’m agonizing over an important decision and it’s driving me crazy. I’m 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…

In the first year after being diagnosed with multiple sclerosis (MS) in 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…

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…

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.

Editor’s 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) isn’t an actual symptom of MS,…

Aubagio (teriflunomide) 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, Robert Zivadinov, a professor of neurology and director of the Buffalo Neuroimaging Analysis Center, said…

Sanofi Genzyme’s multiple sclerosis therapy 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-defect findings in rats and rabbits do not translate to humans. The team presented its…

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 Genentech’s 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 Aubagio’s 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.

Aubagio (teriflunomide) may lead to reversible nail loss, researchers at Italy's University of Bologna 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 — or inflammation of the optic nerve — three months earlier. Their report, “Nail loss after teriflunomide treatment: A new potential adverse event,” 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's 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's Tecfidera (dimethyl fumarate) after a couple of weeks, and her nails started to grow again. This supported doctors’ idea that Aubagio had caused the nail loss, and that it was reversible. Nail growth is similar to that of hair, researchers said. The patient’s 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.  

TG Therapeutics 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) to potentially treat relapsing forms of multiple sclerosis (MS). A special protocol assessment (SPA) is a procedure by which the agency officially evaluates the…

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 Meeting taking…

Sanofi Genzyme will discuss three of its multiple sclerosis therapies at the American Academy of Neurology annual meeting in Boston, April 22-28. The presentations will cover two approved treatments for relapsing MS – Lemtrada (alemtuzumab) and Aubagio (teriflunomide) – and one that has been in a Phase 1 clinical…

A cost-effectiveness analysis of reimbursement recommendations for four relatively new multiple sclerosis (MS) treatments made by agencies in four countries — Australia, Canada, Sweden, and the U.K. — found overwhelming support (88 percent) for either full or restricted reimbursement for each therapy. The analysis, performed by the Decision Resources Group, is…

Sanofi Genzyme presented positive results from its Phase 4 study into patient-reported assessments of Aubagio (teriflunomide), an approved oral treatment for relapsing forms of multiple sclerosis (RMS). Real-world patient responses were reported at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), recently held in London. The clinical…

The Institute of Clinical and Economic Review (ICER) released the early draft of a paper intended to inform a future report evaluating the effectiveness and value of disease-modifying therapies for relapsing-remitting multiple sclerosis (RRMS). The paper, called a draft scoping document, is titled “Disease Modifying Therapies for Relapsing-Remitting Multiple Sclerosis: Effectiveness and…

Genmab announced plans to soon begin a Phase 3 clinical trial program assessing the subcutaneous formulation of ofatumumab as a potential treatment for relapsing multiple sclerosis (MS). The company, working in collaboration with its partner Novartis, will begin enrolling patients in September in trials that will evaluate the efficacy and safety of ofatumumab compared…

Sanofi Genzyme will present new data on its approved multiple sclerosis (MS) treatments — Lemtrada (alemtuzumab) and Aubagio (teriflunomide) — at the 68th annual meeting of the American Academy of Neurology (AAN), taking place in Vancouver, Canada, through April 21, as well as data on investigational therapies in its pipeline. In total, the meeting…

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 “Long-term safety and efficacy of teriflunomide,” were…

Sanofi Genzyme, one of the companies participating in the four-day 10th World Congress on Controversies in Neurology (CONy) in Lisbon, Portugal, that concluded on March 20, 2016, supported several symposiums focused on multiple sclerosis (MS) — including one on B-cell and T-cell therapies. For over a decade, Sanofi Genzyme has worked to develop effective therapies…

Genzyme, a specialty care unit of Sanofi, announced that TV and film actress Madeleine Stowe will host its new online series, “Take Action on MS,” focusing on 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…

The Multiple Sclerosis Society of New Zealand (MSNZ) announced that PHARMAC has agreed with its request to 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 the two treatments, teriflunomide (Aubagio), supplied by Sanofi-Aventis NZ, and dimethyl fumarate (Tecfidera),…

A session titled “Late Breaking News” 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…

Genzyme recently announced results from magnetic resonance imaging (MRI) analysis of participants in the Phase III TEMSO clinical trial showing that Aubagio® (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)…

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).

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 by Genzyme is now financially supported by the state as a first-line oral tablet to treat patients who…

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…

British Columbia’s PharmaCare drug program has announced that it will fund AUBAGIO, a therapy developed by Genzyme for the treatment of multiple sclerosis. AUBAGIO (teriflunomide) 14 mg has been officially added to PharmaCare’s provincial formulary as a first-line oral agent for patients suffering from relapsing remitting multiple sclerosis (RRMS). As…

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 Aubagio® (teriflunomide) 14mg in the provincial drug formulary, indicated for the first-line…

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…