SPMS

FDA, EMA Agree to Review Novartis Therapy Siponimod to Treat SPMS

Novartis is seeking U.S. and European approval of its investigational oral agent siponimodĀ 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…

#EAN2018 – Slowly Evolving Lesions Monitored Using MTR Scans May Be Marker of SPMS Progression

An MRI technique known as magnetization transfer ratio (MTR) correlated closely with theĀ progression ofĀ slowly evolving lesions (SELs) ā€” aĀ specific type of multiple sclerosis lesion ā€” in patients with secondary progressive MS (SPMS). According to the researchers, monitoring changes in SELs ā€” which indicate demyelination and loss of nerve fibers ā€”…

#AAN2018 – Siponimod Lessens Risk of SPMS Progression Independent of Relapses, Trial Data Show

Novartisā€™ investigational oral treatmentĀ 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…

#MSParis2017 – Lemtrada and Tysabri More Efficient Than Older Injectables in Preventing SPMS Onset, Study Finds

Sanofi Genzyme‘s Lemtrada (alemtuzumab) and Biogen’s Tysabri (natalizumab) are more effective in preventing conversion to secondary progressive multiple sclerosis (SPMS) compared to older injectable drugs, researchers from the University of Cambridge in the U.K. reported at the 7th Joint ECTRIMS-ACTRIMS MeetingĀ Oct. 25-28 in Paris. The…

Arise Clinics Are Offering Ocrevus to Multiple Sclerosis Patients in Washington Area

Five clinics in the Washington area that specialize in administering intravenous and injected treatments to people with chronic diseases areĀ now offering the new multiple sclerosis therapy Ocrevus (ocrelizumab). Arise Infusion Therapy ServicesĀ said its staff isĀ helping patients manage the authorization process that many insurers require before agreeing to cover…

New Innate Analysis Fails to Show Clinical Benefit of MIS416 for Secondary Progressive MS Patients

A new analysis of Phase 2 clinical data on Innate Immunotherapeuticsā€™ investigational drug MIS416 to treat secondary progressive multiple sclerosis has confirmed that the drug failed to improve neuromuscular function or patient reported outcomes. The initial evaluation of data obtained from the one-year trial, announced in June, showed disappointing results. These results, gleaned from 70 patients who were randomly designated to receive either weekly injections of MIS416 or a placebo control, failed to demonstrate significant differences or clinically meaningful improvements in patients treated with MIS416 compared to those in the control group. After this initial setback, the Australian company sponsored an additional analysis of the trial results to identify any potential subgroup of clinical responders that could benefit from MIS416 and who might have been masked in the first population-based analysis. However, this post-hoc analysis also failed to show any positive effects of MIS416. Although the detailed report of this second analysis has not yet been released, the Sydney-based company conceded that the final outcome will not change. "All previous reports of MIS416 making a meaningful difference in the lives of many patients must either be dismissed as a very robust placebo effect or the trial failure is attributable to some other reason. It is my view that there may be other reasons," Innate CEO Simon Wilkinson said in a press release. "Patients with SPMS have a complex mix of symptoms and their disease can't be monitored by a simple blood test or MRI scan," he added. "We used the best assessment tools available as recommended by expert practitioners in MS, but we suspect they weren't sensitive enough to pick up the small but potentially significant changes that can lead to a substantial impact on patients' activities of daily living and quality of life." The lack of efficacy of MIS416 shown by the trial results is inconsistent with previous clinical experience, and the benefits reported by those receiving MIS416 for the past eight years.