October 28, 2022 News by Marta Figueiredo, PhD #ECTRIMS2022 ā Long-term Gilenya Reduces Pediatric Relapses Long-term treatment withĀ Gilenya (fingolimod) continues to be safe and lower the rate of relapses in children and adolescents with multiple sclerosis (MS) more than Avonex (interferon beta-1a) does. Thatās according to up to six years of data from the ongoing PARADIGMS Phase 3 trial (NCT01892722), wherein…
September 23, 2022 News by Lindsey Shapiro, PhD Novartis to Petition U.S. Supreme Court to Uphold Gilenya Patent Novartis said it will petition the U.S. Supreme Court to uphold a patent that protects the dosing regimen of Gilenya (fingolimod) that’s approved for relapsing forms of multiple sclerosis (MS). The original patent was not set to expire until the end of 2027, which meant generic versions…
June 21, 2021 News by Marisa Wexler, MS Oral Aubagio Approved in EU for Children With RRMS, Ages 10-17 The European Commission (EC) has approved Aubagio (teriflunomide) for the treatment of children and adolescents, ages 10 to 17, withĀ relapsing-remitting multiple sclerosis (RRMS). Aubagio, approved for adults with RRMS since 2013, is now the first oral therapy available as a first-line treatment for pediatric patients in the European…
May 3, 2021 Columns by Ed Tobias MS News That Caught My Eye Last Week: FDA and Tysabri, COVID-19 and CD20, Gilenya Infections, Therapeutic Lag FDA Rejects Under-the-skin Tysabri for Relapsing MS I expect this decision will be a disappointment for those who had hoped to be able to self-administer highly effective Tysabri as a shot rather than an IV infusion. But I switched from Avonex to Tysabri, because after a few years of…
October 12, 2020 Columns by Ed Tobias MS News That Caught My Eye Last Week: Comparing DMTs, Myelin Repair, Hypertension Gilenya and Tecfidera Similarly Effective at Treating RRMS, Real-world Study Says Gilenya and Tecfidera are both oral disease-modifying therapies. Both meds attempt to limit the inflammatory action of the immune system. Both now have generic versions. And as this story reports, neither appears to have a leg up over…
June 22, 2020 Columns by Ed Tobias MS News That Caught My Eye Last Week: Gilenya and COVID-19, Depression, Switching from Tysabri Gilenya May Help Control Severe Respiratory Disease in COVID-19 This story caught my eye, but not because of the possibility that Gilenya may help someone recover from COVID-19. It caught my eye because this information may give false hope to some people. Some doctors think that at a…
May 11, 2020 Columns by Ed Tobias MS News that Caught My Eye Last Week: Bafiertam, Stem Cell Transplant Damage, Gilenya Study, NurOwn Benefits FDA Approves Bafiertam, Tecfidera Bioequivalent, for Relapsing MS This is the second disease-modifying therapy (DMT) OK’d by the FDA in the past few months. Bafiertam is a delayed-release pill that’s similar to Tecfidera, but it’s said that it has fewer side effects. Unfortunately, its manufacturer hasn’t yet made it…
March 23, 2020 Columns by Ed Tobias MS News that Caught My Eye Last Week: Coronavirus and DMTs, Gilenya and Pediatric MS, Ponesimod for RRMS, Cannabis for Spasticity I’m starting this week by linking to our Coronavirus COVID-19 Information section on the Multiple Sclerosis News Today Forums. My fellow moderator, John Connor, and I have been posting information there from our news writers and columnists about the evolving situation. Have You Tested Positive for Coronavirus…
March 12, 2020 News by Marisa Wexler, MS Ponesimod, Up for Approval, Shows ‘Clear Superiority’ Over Aubagio, Janssen Exec Says PonesimodĀ may soon be a new oral therapy for people with relapsing multiple sclerosis (MS) in Europe, and a filing for its approval in the U.S. is likely within weeks. Janssen Pharmaceuticals, its developer,Ā submitted an applicationĀ to the European Medicines Agency (EMA) inĀ early March, a first ponesimod filing…
March 6, 2020 Columns by Ed Tobias FDA Approval of Investigational DMT Ozanimod May Be Weeks Away By the end of this month, another disease-modifying therapy (DMT) for multiple sclerosis may be available in the U.S. Ozanimod is an investigational daily pill for the treatment of relapsing MS. The Food and Drug Administration is expected to decide…
March 5, 2020 News by Marisa Wexler, MS Janssen Asks EMA to Approve Oral Ponesimod to Treat Relapsing MS JanssenĀ has submitted an application toĀ the European Medicines Agency (EMA) asking that ponesimodĀ be approved as an oral treatment for adults with relapsing multiple sclerosis (MS) in the European Union. Ponesimod (formerly ACT-128800) is an experimental treatment that targets theĀ sphingosine-1-phosphate receptor…
January 24, 2020 Columns by Ed Tobias April Hester Is Lacing Up Her MS Hiking Boots Again When I wrote about April Hester two years ago, she and her husband, Bernie, had just finished hiking the 500 miles of South Carolina’s Palmetto Trail. That’s no small accomplishment for anyone, but it was a particularly special achievement…
December 11, 2019 News by Joana Carvalho, PhD Tysabri May Promote Inflammatory B-Cell Activation in MS Patients, Study Says Tysabri (natalizumab), an effective T-cell targeting treatment for multiple sclerosisĀ (MS),Ā seems to also promote the activation of pro-inflammatory immune B-cells in people with this disease, a studyĀ found. The study, “Natalizumab promotes activation and pro-inflammatory differentiation of peripheral B cells in multiple sclerosis patients,” was published in the…
December 9, 2019 Columns by Ed Tobias MS News that Caught My Eye Last Week: Gilenya Generics, MS Pain and Fatigue Toolkit, Profit Drives MS Meds Prices, MS and Sugar Link FDA Approves Three Generic Versions of Novartisā Gilenya for Treating Relapsing MS It’s always nice to hear about generics becoming available to replace expensive multiple sclerosis treatments. But I wonder whether these generics will cost less than the brand-name medication. Will their availability help to drive down the price…
October 28, 2019 Columns by Ed Tobias MS News that Caught My Eye Last Week: Cognitive Impairment, Genetic Variant Risk Factor, Protein Biomarkers, Gilenya Study Higher Intellectual Ability, Early-life Physical Activity May Protect Against Cognitive Impairment in MS, Study Suggests The finding that physical activity provides a protective effect for cognitive abilities makes sense to me. I recently listened to a webinar discussing brain atrophy, which has a direct relationship with cognitive impairment, and…
October 17, 2019 News by Patricia Inacio, PhD Rituximab Linked to Greater Risk of Infections in MS Patients in Real-world Swedish Study Newer disease-modifying treatments for multiple sclerosis (MS) are effective but also known to carry a greater risk of infections in a patient group already more likely to be troubled by infections ā and this higher risk is particularly evident in treatment with rituximab, a DMT often used off-label in…
September 19, 2019 Columns by Tamara Sellman Need to Know: What Is the JC Virus? Editor’s note: “Need to Knowā is a series inspired by common forum questions and comments from readers. Have a comment or question about MS? Visit our forum. This week’s question is inspired by the forum topicĀ “Does PML worry you?” from April 18. The world of multiple sclerosis (MS)…
September 11, 2019 News by Patricia Inacio, PhD #ECTRIMS2019 – 10-year Data Confirm Long-term Benefits of Biogen’s Tecfidera for RRMS New 10-year data from the Phase 3 ENDORSE trial confirms the long-term benefits of Biogenās TecfideraĀ for patients with relapsing-remitting multiple sclerosisĀ (RRMS), the most common form of this disease. Real-world data from another study also showed Tecfidera to be superior to several other disease-modifying therapies for relapsing MS,…
June 13, 2019 Columns by Tamara Sellman Need to Know: What Is the Blood Brain Barrier? Editor’s note: “Need to Knowā is a series inspired by common forum questions and comments from readers. Have a comment or question about MS? Visit our forum.Ā This week’s question is inspired by the forum topicĀ “How the Blood Brain Barrier May Thwart MS Progression” from Feb. 9, 2017. What…
June 3, 2019 Columns by Ed Tobias MS News that Caught My Eye Last Week: Preventive MS Treatment, Clinical Trial Guidelines for Kids, Stress, and Gut Bacteria Cyxone Nears First-in-human Trial for Investigational Preventive MS Treatment T20K Multiple sclerosis can be treated but it can’t be prevented ā at least not yet. But these researchers hope that a substance derived from a natural plant protein called T20K will be able to ease or even prevent MS…
May 2, 2019 Columns by Tamara Sellman Need to Know: What Are Patient Assistance Programs? Editor’s note: “Need to Know” is a series inspired by common forum questions and comments from readers. Have a comment or question about MS? Visit our forum. This week’s question is inspired by the forum topicĀ “Could US Govāt Probe Threaten Pharma Patient Assistance Programs?” from Oct. 12, 2018.
March 4, 2019 Columns by Ed Tobias MS News that Caught My Eye Last Week: New DMT, Stem Cell Trial, Pediatric MS Treatment Study FDA Will Review New Drug Application of Diroximel Fumarate for Relapsing Forms of MS The good news: Another disease-modifying therapy (DMT) has taken a step toward approval in the U.S. The discouraging news: It’s another DMT designed to treat relapsing forms of multiple sclerosis. More than a…
January 22, 2019 News by Jonathan Grinstein Certain Treatments Linked to Lower Risk of Secondary Progressive MS, Study Shows Initial treatment of relapsing-remitting multiple sclerosis (RRMS) with Gilenya (fingolimod), Tysabri (natalizumab), or Lemtrada (alemtuzumab) is associated with a lower risk of conversion to secondary progressive multiple sclerosis (SPMS), compared with interferon beta or Copaxone (glatiramer acetate), a study reports. Findings also showed that…
December 20, 2018 Columns by Tamara Sellman Need to Know: Managing Depression and Anxiety When You Have MS Editor’s note: “Need to Know” is a series inspired by common forum questions and comments from readers. Have a comment or question about MS? Visit our forum. This week’s question is inspired by the forum topicĀ “Anxiety and Depression with MS” from April 30.
December 4, 2018 Columns by Ed Tobias How Worried Should We Be About MS Medication Side Effects? Over the past couple of weeks, two warnings have been issued about side effects of multiple sclerosis (MS) medications. First, the U.S. Food and Drug Administration warned about a slight risk of seriously worsening MS symptoms if someone who is using the disease-modifying therapy (DMT) Gilenya (fingolimod) stops using…
December 3, 2018 Columns by Ed Tobias MS News that Caught My Eye Last Week: MRI Dyes, Lipids and MS, Gilenya Advisory, Possible Stem Cell Trial Artificial Intelligence May Help Reduce Dosage of Gadolinium in MRIs, Researchers Suggest There’s been concernĀ recently about the accumulation of gadolinium in the brains of people who’ve had MRIs. Gadolinium is the dye that’s used to provide the “contrast” that can highlight lesions in the brain that might…
November 30, 2018 News by Alice MelĆ£o, MSc Gilenya Now Approved in Europe to Treat Children, Adolescents with RRMS Gilenya (fingolimod) was approved by the European Commission as a treatment for children and adolescents, ages 10 to 17, with relapsing-remitting multiple sclerosis (RRMS), Novartis announced. The therapy is already approved in Europe to treat RRMS patients 18 and older. With this newest decision, Gilenya has become…
November 27, 2018 Columns by Ed Tobias FDA Warns of Possible Dangers of Stopping Gilenya If you are being treated with Gilenya, take note. The U.S. Food and Drug Administration is warning that if you stop using Gilenya (fingolimod), there’s a chance your MS could become worse. The FDA issued a safety alert saying that this only happens rarely, but when it does, the…
September 26, 2018 News by Jose Marques Lopes, PhD DMTs Are Cost-Effective and Help to Slow MS Progression, 10-Year Study from UK Reports Four disease-modifying therapies (DMTs) for Ā multiple sclerosisĀ āĀ Avonex, Rebif, Betaferon, and CopaxoneĀ ā are cost-effective and reduce disease progression in MS patients, especially those with relapsing-remitting disease, according to 10-year, real-world results from U.K.ās MS Risk Sharing Scheme (RSS). But the long-term benefits observed wane over…
September 17, 2018 News by Patricia Inacio, PhD Gilenya More Effective Than Avonex in Lowering Relapse Rates, New Lesions in Children with Relapsing MS, Phase 3 Trial Shows Two years of treatment with oral GilenyaĀ (fingolimod) significantly reduced the rate of relapses when compared toĀ AvonexĀ (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…