Novartis

Up to half of women with multiple sclerosis (MS) who stop treatment with Gilenya (fingolimod) when planning to become pregnant will experience a relapse during pregnancy, according to a new study. The findings also revealed relapses over the first six months after giving birth in a quarter of…

Mouse studies of siponimod — a potential progressive multiple sclerosis (MS) treatment that’s up for approval in the U.S. and EU — were among presentations given by Novartis at the 34th European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), held Oct. 10-12 in Berlin. Animal work might seem…

Levels of proposed biomarker neurofilament light chain (NfL) are associated with therapeutic effects of disease-modifying treatments (DMTs) in relapsing-remitting multiple sclerosis (RRMS) patients, according to a real-world study. Study findings also revealed that treatment with either Lemtrada (alemtuzumab, marketed by Sanofi Genzyme), Gilenya (fingolimod, marketed by Novartis), Tecfidera (dimethyl fumarate, marketed…

Patients with relapsing-remitting multiple sclerosis (RRMS) who switch to Tysabri (natalizumab) after relapses on first-line treatment with other medications show greater relapse reduction and less disability progression than those switching to Gilenya (fingolimod), according to a real-world study. The research, “Comparative effectiveness of switching…

Novartis is seeking U.S. and European approval of its investigational oral agent siponimod to treat adults with secondary progressive multiple sclerosis (SPMS). The U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application, while the European Medicines Agency (EMA) has accepted for review…

Thousands of scientists, doctors, pharmaceutical company executives and others — representing about 100 countries — will meet for three days to discuss and debate the latest developments in multiple sclerosis (MS) at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis, best known as…

The Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency (EMA), has recommended that Gilenya (fingolimod) be approved to treat children and adolescents, ages 10 to 17, with relapsing-remitting multiple sclerosis (RRMS). If the CHMP opinion is accepted, Gilenya — marketed by…

Eighteen months after its entrance into the U.S. market, Genentech’s Ocrevus (ocrelizumab) has become the monoclonal antibody of choice to treat patients with multiple sclerosis (MS), according to a survey of nearly 100 neurologists across the U.S. Self-reported use of Ocrevus for the third quarter of 2018 surpassed…

Two years of treatment with oral Gilenya (fingolimod) significantly reduced the rate of relapses when compared to Avonex (interferon beta-1a) intramuscular injections in children and adolescents with relapsing forms of multiple sclerosis (RMS), according to Phase 3 clinical trial results. Additionally, Gilenya (marketed by Novartis) decreased the number of central nervous…

Tecfidera (dimethyl fumarate) and Gilenya (fingolimod) are equally effective in treating multiple sclerosis (MS), but Tecfidera shows higher rates of discontinuation, according to a real-world study. The study, “Discontinuation and comparative effectiveness of dimethyl fumarate and fingolimod in 2 centers,” was published in the journal Neurology Clinical…

Discontinuing Gilenya (fingolimod) treatment and starting on rituximab therapy may be more complicated than originally thought. A new report chronicles the medical journey of a man with multiple sclerosis (MS) treated with these drugs, and proposes a new treatment regimen. Both Gilenya (an approved MS therapy marketed by…

Multiple sclerosis (MS) patients may experience severe disease exacerbation after switching from Novartis’ Gilenya (fingolimod) to Sanofi Genzyme’s Lemtrada (alemtuzumab), a case report suggests. This unexpected high disease activity raises questions about managing MS through the consecutive use of immunotherapies. The case report, “Unexpected high multiple…

African-Americans with relapsing–remitting multiple sclerosis (RRMS) show higher adherence and greater satisfaction when treated with oral Gilenya (fingolimod, by Novartis) than with injectable therapies, according to a new study. The research, “Treatment retention on fingolimod compared with injectable multiple sclerosis therapies in African-American patients: A…

Shortening the washout period to four weeks when switching from Biogen’s Tysabri to Novartis’ Gilenya is safe and reduces the chances of experiencing a disease flare in patients with relapsing-remitting multiple sclerosis (RRMS), a small Swiss study found. A four-week washout reduced the risk of having a disease relapse or an increase in disease activity, compared with an eight-week washout period, for two years after switching from Tysabri to Gilenya. Although Tysabri effectively slows worsening of MS symptoms and the appearance of disease flares, its use is under a strict risk management plan as it heightens the risk of developing a rare and life-threatening brain infection called progressive multifocal leukoencephalopathy, also known as PML. Some patients may switch to Gilenya, an alternative disease-modifying therapy for RRMS. Gilenya has been associated with a lower risk of PML infection and seen to reduce relapses, disability worsening, and the appearance of new brain lesions on clinical trials. It also is the only therapy approved by the U.S. Food and Drug Administration for children with MS as young as 10. When switching from Tysabri to Gilenya, it is important to consider the washout period, which is the period when the patient is taken off medications. If too long, it may lead to disease reactivation, which can be even stronger than before starting Tysabri. There is little evidence about the optimal length of washout periods, but a Phase 3 trial showed that an eight-week washout between Tysabri and Gilenya was beneficial compared with longer washouts of 12 or 16 weeks. The eight-week washout enabled more RRMS patients to become free from relapses and lowered disease activity. To study if a shorter washout period of four weeks further reduced the risk of MS reactivation, researchers conducted an open-label, observational study at the University Hospital, Basel, Switzerland. The study enrolled 25 RRMS patients who were appointed to switch from Tysabri to Gilenya. Participants were assigned to either a four-week or an eight-week washout period, and were followed for two years after switching to Gilenya. Although patients were older in the four-week washout group, disease activity and disability scoreswere not significantly different between groups at the beginning of the study. Relapses, disability scores, and disease activity on magnetic resonance imaging scans were recorded at baseline and weeks 8, 12, 16, 20 32, 56, and 108. In the first year (week 56) the proportion of patients with disease flare-ups or disease activity on MRI was not significantly different between the two washout groups, affecting 55.6% and 62.5% of the patients who had a four-week and an eight-week washout, respectively. However, at the end of the two-year follow-up (week 108), recurrent event analysis showed that patients who were on the four-week washout group were 77% less likely to experience relapses. The combined risk for relapse or disease activity on MRI also was 58% lower in the four-week group, compared with those who had an eight-week washout. In addition, researchers found that patients who had flares more frequently in the year before discontinuing Tysabri also had a nearly four times higher risk of experiencing relapses in the first year after switching to Gilenya. This suggests that the number of relapses before switching from Tysabri can predict disease reactivation once on other disease-modifying therapies. Both washout periods were deemed safe, with no serious adverse side effects or cases of opportunistic infections, including PML, being reported. Researchers emphasized, however, that the findings need to be confirmed in larger studies.

People with relapsing-remitting multiple sclerosis in Denmark show high rates of adherence to treatment with Gilenya (fingolimod), and give the therapy high marks in terms of satisfaction and quality of life, a long-term study of its use by RRMS patients reports. The study, “High treatment adherence, satisfaction, motivation,…

Genentech‘s Ocrevus (ocrelizumab), approved in March 2017, has fueled a sea change in the treatment of multiple sclerosis (MS) patients in the U.S., leading to an increased interest in disease-modifying therapies (DMTs) for progressive forms of MS. Now, other potential treatment choices for progressive MS forms will likely…

Levels of neurofilament light chain are a reliable predictor of disease worsening and progression in relapsing-remitting MS (RRMS) patients, a new study shows. Moreover, treatment with Gilenya (fingolimod), marketed by Novartis, can reduce the levels of NfL for up to 10 years. These findings were shared recently in the presentation “…

Gilenya (fingolimod) and Tecfidera (dimethyl fumarate) are equally effective as first-line treatments in people with relapsing-remitting multiple sclerosis (RRMS), but Gilenya may be of slightly more benefit to those who switch from a previous injectable therapy, according to a real-world study of patients in Italy. The study, “…

Young adults with multiple sclerosis (MS) have higher relapse rates and respond better to Gilenya treatment compared to the overall MS population, data from a post hoc analysis of three separate trials show. The study, “Relapse Rate and MRI Activity in Young Adult Patients With Multiple…

In the United States, the government can do very little to control the costs of our expensive MS medications. In the United Kingdom, it’s a different story. The U.K. has an organization called the National Institute for Health and Care Excellence, better known as NICE. NICE provides healthcare…

Treatment with Gilenya (fingolimod) is associated with treatment satisfaction, which, in turn, is linked to a better quality-of-life in patients with relapsing-remitting multiple sclerosis (RRMS), a study has found. Gilenya, an oral disease-modifying treatment (DMT) for RRMS developed by Novartis, has been available in France since 2011. Studies have…

Complications from Gilenya Treatment Managed Successfully, Case Report Says This wasn’t a minor complication. It was a version of PML, a brain disease that can be fatal. PML is also a known side effect of Tysabri, so the report of a successful treatment should be important to…

Until about a week ago, no medication was approved in the U.S. to treat patients with pediatric-onset MS (POMS). Now there is one. The Food and Drug Administration (FDA) has given its OK to use Gilenya (fingolimod) to treat relapsing MS in children and adolescents starting at…

A case study reported the successful management of a multiple sclerosis (MS) patient who developed a rare condition in the brain — progressive multifocal leukoencephalopathy (PML) — due to treatment with Novartis Pharmaceutical’s Gilenya (fingolimod). The study, titled “Fingolimod-associated PML with mild IRIS in MS: A…

After an agreement to lower their prices, four treatments for relapsing multiple sclerosis — Biogen’s Avonex and Merck KGaA‘s Rebif (both interferon beta-1a), Novartis’ Extavia (interferon beta 1b), and Teva’s Copaxone (glatiramer acetate) — were recommended as cost-effective and long-term therapy options within the National Health Service…

Gilenya (fingolimod) has become the first disease-modifying therapy approved by the U.S. Food and Drug Administration (FDA) to treat children and adolescents with relapsing forms of multiple sclerosis (MS). This expanded approval allows Gilenya, previously indicated for adults patients 18 or older, to be used to treat pediatric relapsing MS…

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…

Here in the U.S., the price we pay for medications is complicated. The usual process is for a pharmaceutical company to set a high price for a medication when it first hits the market. But, like buying a car, that “sticker” price is negotiable. Health plans use pharmaceutical benefit…

#AAN2018 – Stem Cell Transplant is Effective Treatment for ‘Aggressive’ MS, Study Shows I like the fact that a study shows that stem cell transplant treatment is effective for aggressive MS. I love the fact that the efficacy was dramatic, reducing the Expanded Disability Status Scale (EDSS) levels…

Novartis’ investigational oral treatment siponimod (BAF312) reduces the risk of disability progression in patients with secondary progressive multiple sclerosis (SPMS), a new analysis of Phase 3 trial results show. Using what the company describes as more accurate methods to assess siponimod effect’s on progression risk, necessary because the…