March 17, 2020 News by Larry Luxner TV Personality Montel Williams Launches ‘My MS: Second Act’ A little over 20 years ago, Montel Williams learned once and for all that he had multiple sclerosis (MS). But that determination should have happened long before then, said the well-known TV personality ā whoās made fighting the neurodegenerative disease his lifeās mission. Williams, 63, was the star attraction…
March 13, 2020 News by Marta Figueiredo, PhD #ACTRIMS2020 – Ofatumumab Self-injection Pen May Be ‘Very Attractive’ Option for Relapsing MS Monthly under-the-skin injections of NovartisāĀ investigational candidate ofatumumab show promise as a convenient, effective, and safe therapeutic option for people with relapsing multiple sclerosisĀ (MS). Data from the ASCLEPIOS and APLIOS clinical trials showed that ofatumumab ā currently under regulatory review for possible approval in the U.S. and Europe…
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 News by Iqra Mumal, MSc Health Canada Approves Mayzent to Treat Active SPMS Health Canada has approved Novartis‘sĀ MayzentĀ (siponimod)Ā for the treatment of adults with activeĀ secondary progressive multiple sclerosisĀ (SPMS) to delay the progression of physical disability. Active disease is determined either by the presence of relapses or magnetic resonance imaging features characteristic of inflammatory activity. Multiple sclerosis (MS)…
March 2, 2020 News by Ana Pena PhD #ACTRIMS2020 – Ofatumumab Self-injection Pen Equivalent to Prefilled Syringe, APLIOS Trial Shows Using a patient-friendly autoinjector pen to take monthly doses of ofatumumab ā an investigationalĀ B-cell therapy for relapsing multiple sclerosis (MS) ā is bioequivalent to delivering it via a prefilled syringe, and would allow self-administration of the treatment at home, a study shows. Equal effects…
February 25, 2020 News by Patricia Inacio, PhD Novartis’ Ofatumumab for Relapsing MS Up for Possible Approval by FDA and EMA Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) will review Novartis‘ applications seeking regulatory approval of ofatumumab, anĀ investigational B-cell therapy for the treatment of relapsing forms ofĀ multiple sclerosisĀ (MS) in adults. Novartis’ applications for ofatumumab ā which has the…
January 24, 2020 News by Patricia Inacio, PhD Mayzent Helps Regulate the Immune System in SPMS, Study Shows Mayzent (siponimod), an approved oral therapy for activeĀ secondary progressive multiple sclerosisĀ (SPMS), promotes a more regulatory immune system, which may explain its added benefits for SPMS, new clinical data show. The study āSiponimod enriches regulatory T and B lymphocytes in secondary progressive multiple sclerosisā was published in the…
January 21, 2020 News by Marta Figueiredo, PhD Mayzent Approved in Europe as First Oral Treatment for Active Secondary Progressive MS TheĀ European CommissionĀ has approvedĀ Novartis‘s MayzentĀ (siponimod) as the first oral treatment for adults with active secondary progressive multiple sclerosisĀ (SPMS). Active SPMS is defined by the presence of evident relapses or the detection of inflammatory activity in brain lesions on imaging scans. āAs the only indicated oral therapy proven for…
December 19, 2019 News by Ana Pena PhD Treatment Begins in Part 2 of Trial of Software App Addressing Depression in MS, Pear Says Pear Therapeutics announced that a first patient is being treated in Part 2 of its feasibility trialĀ of Pear-006, a software application that, given along with a disease-modifying therapy, delivers cognitive behavioral therapy and other neurobehavioral approaches to ease depressionĀ in people with multiple sclerosisĀ (MS). Pear-006, being developed…
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 6, 2019 News by Joana Carvalho, PhD FDA Approves Three Generic Versions of Novartis’ Gilenya for Treating Relapsing MS The U.S. Food and Drug Administration (FDA) approved three generic versions of Gilenya (fingolimod) for the treatment of adults with relapsing forms of multiple sclerosis (MS). A generic is a nearly identical, lower-priced version of an original brand medication. The three generic applications approved Thursday by the…
November 22, 2019 News by Ana Pena PhD Ocrevus Top Choice of US Neurologists for Active SPMS, But Mayzent and Mavenclad Gaining Interest, Report Says Genentech‘sĀ OcrevusĀ (ocrelizumab) continues to be the most prescribed medication to reduce inflammatory disease in people with active secondary progressive multiple sclerosisĀ (SPMS) amongĀ U.S. neurologists, even though Novartis’Ā MayzentĀ (siponimod) and EMD Serono’sĀ MavencladĀ (cladribine) were approved in March to treat this same MS…
November 18, 2019 News by Iqra Mumal, MSc Mayzent Approved in Australia as First Treatment for Secondary Progressive MS Novartisās MayzentĀ (siponimod) has been approved by Australiaās Therapeutic Goods Administration (TGA) for the treatment of secondary progressive multiple sclerosis (SPMS), making it the first therapy to be approved for this use in Australia. SPMS is a form of MS that develops after the onset of…
November 15, 2019 News by Grace Frank CHMP Favors Mayzent as Oral Treatment Specifically for Active SPMS Patients in EU The Committee for Medicinal Products for Human Use (CHMP) issued an opinion supporting MayzentĀ (siponimod) as an oral treatment specifically for adults with active secondary progressive multiple sclerosisĀ (SPMS) in the European Union. Opinions released by CHMP, an arm of the European Medicines Agency (EMA), carry weight and are…
November 7, 2019 News by Patricia Inacio, PhD Generic Version of Gilenya, pms-Fingolimod, Now Available for RRMS Patients in Canada PharmascienceĀ recently launched pms-Fingolimod, a generic version of NovartisāĀ GilenyaĀ (fingolimod),Ā to treat adults with relapsing-remitting multiple sclerosisĀ (RRMS) in Canada. The new generic is now available in that country, and has demonstrated efficacy and safety similar to Gilenya. GenericĀ medicines are chemically identical to the original branded therapy, but carry a…
October 22, 2019 News by Joana Carvalho, PhD Long-term Gilenya Treatment Safe and Effective for Relapsing MS Patients, Phase 3 Trial Shows Long-term treatment with Gilenya (fingolimod) in patients with relapsing forms of multiple sclerosis (MS) is safe and effective, results from a Phase 3 trial show. Trial findings were reported in the study, “Extended treatment with fingolimod for relapsing multiple sclerosis: the 14-year LONGTERMS study results,” published in…
October 15, 2019 News by Ana Pena PhD #ECTRIMS2019 – Ofatumumab Part of ‘Magnificent Success Story’ for MS, ASCLEPIOS Trial Investigator Says Ofatumumab, anĀ investigational B-cell therapy being developed by Novartis, demonstrated encouraging results in lowering relapse rates and active brain lesions in people with relapsing multiple sclerosis (MS) enrolled in the ASCLEPIOS trials. For Stephen L. Hauser, MD, an investigator in the ASCLEPIOS trials, these results represent a…
October 11, 2019 News by Ana Pena PhD Mavenclad, Ocrevus Use Rising in EU as Injectables and Tysabri Decline, Spherix Reports Prescriptions of two multiple sclerosisĀ (MS) treatments ā Ā Merck KGaA‘s Mavenclad (cladribine) and Roche‘s Ocrevus (ocrelizumab) ā have been rising in Europe over the past six months, bolstered by greater market access and compassionate use programs, according to a survey of 250 EU neurologists run…
September 20, 2019 News by Ana Pena PhD #ECTRIMS2019 – Ahead for Mavenclad: Fuller Understanding of What Makes It ‘Unique,’ Serono Exec Says in Interview Real-world data continues to support the safety and effectiveness ofĀ MavencladĀ (cladribineĀ tablets) in treating multiple sclerosis (MS), and several studies underway will help scientists gain in-depth understanding of how Mavenclad works, its impact on the immune system, and the durability of its benefits, an executive with EMD SeronoĀ said in an…
September 17, 2019 News by Ana Pena PhD #ECTRIMS2019 ā Ofatumumab Superior to Aubagio in Lowering Relapse Rates and Lesions, Data Show Monthly under-the-skin injections of ofatumumab are superior to AubagioĀ (teriflunomide) to treat relapsing-remitting multiple sclerosis (RRMS) and secondary progressive multiple sclerosis (SPMS), leading to over 50% reduction in relapse rates, and more than a 90% reduction in active brain lesions, compared with Aubagio, results from ASCLEPIOS I…
September 16, 2019 News by Ana Pena PhD #ECTRIMS2019 – Mayzent Reduces Risk of SPMS Patients Becoming Wheelchair Bound, Data Show Mayzent (siponimod) reduces the risk of people with secondary progressive multiple sclerosis (SPMS) becoming dependent on a wheelchair, a new analysis of the EXPAND study shows. These findings further corroborate prior trial data demonstrating that Mayzent use delays disability progression and cognitive decline in SPMS patients. The results…
September 16, 2019 News by Jose Marques Lopes, PhD #ECTRIMS2019 – Newer DMTs More Effective Than Older Injectables in Pediatric MS, Study Says Using newer disease-modifying therapies (DMTs) as an initial treatment for children and adolescents with multiple sclerosis (MS) or clinically isolated syndrome (CIS) is associated with fewer relapses and brain lesions compared to the use of older and injectable DMTs, according to a real-world study in the U.S.
September 16, 2019 News by Patricia Inacio, PhD #ECTRIMS2019 – Anti-epileptic May Help to Stop Disability Progression, Study Suggests Oxcarbazepine, an anti-epileptic medicine, given in combination with a disease-modifying therapy (DMT) may help to stop disability progression in multiple sclerosis (MS) patients, results of Phase 2 trial suggest. Monica Marta, PhD, withĀ Queen Mary University of LondonĀ and Barts Health NHS Trust/The Royal London HospitalĀ presented the data at the…
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,…
September 3, 2019 News by Jose Marques Lopes, PhD Ofatumumab Better at Easing Relapse Rates and Slowing MS Progression Than Aubagio, Phase 3 Data Show Monthly injections of ofatumumabĀ led to more clinically meaningful reductions in relapse rates and delayed disability progression than did daily treatment withĀ AubagioĀ (teriflunomide) tablets in people with relapsing forms of multiple sclerosisĀ (MS), results from two Phase 3 trials showed. Ofatumumab, formerly known as OMB157, is a potent, self-administered…
August 28, 2019 News by Jose Marques Lopes, PhD Mavenclad Cost-Effective Treatment for At-risk RRMS Patients Compared to Other DMTs, Dutch Study Finds Treating at-riskĀ relapsing-remitting multiple sclerosis (RRMS) patients is most cost-effective withĀ MavencladĀ (cladribine) tablets when compared to Gilenya (fingolimod), Lemtrada (alemtuzumab) or Tysabri (natalizumab),Ā according to a study in Dutch patients. The study, āCost Effectiveness of Cladribine Tablets for the Treatment of Relapsing-Remitting Multiple Sclerosis in…
August 21, 2019 News by Ana Pena PhD Gilenya, Aubagio, Tysabri, Tecfidera Dominate MS Therapy Switches in Europe, Spherix Survey Finds Novartis‘ Gilenya (fingolimod), Sanofi Genzyme‘sĀ Aubagio (teriflunomide), andĀ BiogenāsĀ TysabriĀ (natalizumab) and Tecfidera (dimethyl fumarate) are the top disease-modifying therapies to which patients with multiple sclerosis (MS) have most frequently switched in…
August 16, 2019 News by Marisa Wexler, MS MS Therapies Among Limited Offerings Through AllianceRx Walgreens Prime Medications for treating certain rare and chronic conditions, Ā including multiple sclerosis (MS), are now available from the specialty and home delivery pharmacy AllianceRx Walgreens Prime, the company announced. The newly included specialty medications are all limited distribution drugs (LDDs), which means the drug manufacturers have signed agreements giving very…
July 29, 2019 News by Patricia Inacio, PhD Early Gilenya Treatment Lessens Disability Progression and Disease Activity in Young RRMS Patients, Study Shows Early and continuous treatment with Gilenya (fingolimod) in youngĀ people ā those ages 30 years or younger ā with relapsing-remitting multiple sclerosis (RRMS) decreases the risk of disability progression, and lowers annual relapse rates and brain lesions, new analysis from the FREEDOMS and FREEDOMS II trials show. The…
July 23, 2019 News by Patricia Inacio, PhD Gilenya Approved in China for Adults and Children with Relapsing MS Gilenya (fingolimod) has been approved in China as a disease-modifying therapy to treat adults and children, ages 10 and older, with relapsing forms of multiple sclerosis (MS). Gilenya,Ā marketed byĀ Novartis, is an oral disease-modifying treatment for relapsing MS. It acts by binding and modulating receptors…