A generic formulation of Zeposia (ozanimod), which won tentative approval for treating multiple sclerosis (MS) from the U.S. Food and Drug Administration (FDA), will be manufactured and supplied by Synthon, based in the Netherlands. Tentative approval means the generic version has met all FDA requirements for…

About two-thirds of people with relapsing forms of multiple sclerosis (MS) remained completely free from relapses over six years of treatment with Zeposia (ozanimod) in the DAYBREAK clinical trial. Most also saw no sustained disability progression during that period and the mean number of new or enlarging lesions…

Treatment with Zeposia (ozanimod) during early pregnancy may be safe for women with multiple sclerosis (MS), or inflammatory bowel diseases,  a recent study suggests. Specifically, receiving the treatment during the first trimester of pregnancy didn’t increase the incidence of fetal malformations or…

More than three-quarters of people with relapsing forms of multiple sclerosis (MS) who received Zeposia (ozanimod) in the RADIANCE clinical trial and its extension study still haven’t experienced confirmed disability progression after eight years of follow-up, new data shows. Among those who progressed, about half of disability progression…

Long-term use of Zeposia (ozanimod) did not adversely affect the heart of relapsing multiple sclerosis (MS) patients treated for one or two years in Phase 3 clinical trials, with no clinically significant changes in cardiac function reported. Data on people enrolled in the two studies were retrospectively evaluated, as the therapy…

Long-term treatment with Zeposia (ozanimod) stabilizes or even improves cognitive function in adults with relapsing forms of multiple sclerosis (MS), particularly among those with greater brain volumes. That’s according to five years of data from the completed SUNBEAM Phase 3 clinical trial (NCT02294058) and the ongoing…

Novartis’ Mayzent (siponimod) and Kesimpta (ofatumumab) are gaining ground among multiple sclerosis (MS) therapies in Canada, according to the latest Spherix Global Insights’ report. “Following an eventful 2021 that included the launch of two new brands — Novartis’ Kesimpta and BMS’ Zeposia — and generic versions of Biogen’s…

For the first time, researchers have brought to light the precise three-dimensional structure of Mayzent (siponimod) as it binds to its molecular target, the sphingosine 1-phosphate receptor 1 (S1P1). These findings are expected to aid in developing next-generation MS therapeutics with better selectivity for S1P1, enhancing their potency while reducing…

Tecfidera (dimethyl fumarate) and Aubagio (teriflunomide) are the preferred disease-modifying treatments for managing relapsing-remitting multiple sclerosis (RRMS) in Canada, according to a report from Spherix Global Insights. The report was part of Spherix’s RealTime Dynamix: Multiple Sclerosis (Canada) service, which collects data on market trends of MS…

Ocrevus (ocrelizumab) continues to be the most commonly prescribed therapy for progressive forms of multiple sclerosis (MS), including primary progressive MS (PPMS) and secondary progressive MS (SPMS), according to an analysis from the market intelligence firm Spherix Global Insights. However, other therapies are “gaining traction” among…

Larger declines with treatment in blood levels of neurofilament light chain (NfL), a marker of nerve cell damage, are associated with fewer brain lesions, less brain shrinkage, and lower relapse rates in people with relapsing forms of multiple sclerosis (MS), a study reported. These results, based on a post-hoc analysis…

Mayzent (siponimod) and Zeposia (ozanimod), the two sphingosine-1-phosphate (S1P) receptor modulators most recently approved in Canada for treating multiple sclerosis (MS), showed strong launches in the country, according to the latest Spherix Global Insights’ report. However, due to several internal and external factors, sustained relevance of these…

NICE Again Says No to Adding Zeposia to Health System for England and Wales Reading this news, I’m again reminded of the major difference between the healthcare system in the U.S. and those in most of the rest of the world. While the systems outside the U.S. provide most…

The National Institute for Health and Care Excellence (NICE) has maintained its initial draft recommendation and will not recommend that Zeposia (ozanimod) be added to the National Health Service (NHS) of England and Wales. This final decision on the cost effectiveness of the oral therapy means Zeposia will…

Treatment with Zeposia (ozanimod) significantly reduces the risk of relapse, decreases the proportion of patients experiencing a relapse, and has a better safety profile than Aubagio (teriflunomide) for people with relapsing multiple sclerosis (MS), according to an indirect comparison of clinical trial data.

Tecfidera (dimethyl fumarate), Gilenya (fingolimod), and Ocrevus (ocrelizumab) are losing ground to more recent therapies among U.S. multiple sclerosis (MS) patients switching treatment, according to the latest Spherix Global Insights’ report. The launch of MS generics, bioequivalents, and new brands in the U.S. market over the past year has increased…

As winner of the Lyfebulb and Bristol Myers Squibb Innovation Challenge in multiple sclerosis (MS), Evolution Devices will use the $25,000 in prize money to further develop a smart stimulation therapy that seeks to improve patient mobility. The innovative electrical device under development by Pierluigi Mantovani, co-founder…

The Scottish Medicines Consortium (SMC) has approved Zeposia (ozanimod) for the treatment of active relapsing-remitting multiple sclerosis (RRMS). Zeposia is sold as a tablet, to be taken by mouth once daily. The SMC has recommended that Zeposia be prescribed for people with RRMS who experience relapses or have evidence of…

Tecfidera Safe and Effective Over Long Term in Children With RRMS, Trial Shows In my view, too little attention has been paid to treating children and teens with MS between the ages of 10 and 18. Though things seem to be improving, only one disease-modifying therapy, Novartis’ Gilenya (fingolimod),…

The National Institute for Health and Care Excellence (NICE) does not recommend Zeposia (ozanimod) be available at low or no cost through the National Health Service (NHS) to treat adults with active relapsing-remitting multiple sclerosis (RRMS) living in England and Wales. In a recent draft recommendation, NICE stated that …

Multiple Sclerosis News Today brought you daily coverage of the latest scientific findings, treatment developments, and clinical trials related to multiple sclerosis (MS) throughout 2020, a year marked by the COVID-19 pandemic. We look forward to reporting more news to patients, family members, and caregivers dealing with MS during…

Health Canada has approved Zeposia (ozanimod), an oral daily treatment for people with relapsing-remitting multiple sclerosis (RRMS) in the country. Approval does not assure that Zeposia will be available to Canadian patients at no or low cost, as publicly funded prescription plans are largely administered by each…

Among oral sphingosine-1-phosphate (S1P) receptor modulators for multiple sclerosis (MS), Novartis’s Gilenya (fingolimod) remains physicians’ favorite in the U.S., but prescriptions of recently-launched Bristol Myers Squibb’s Zeposia (ozanimod) are beginning to rise, according to a survey conducted by Spherix Global Insights. Also, COVID-19 not…

COVID-19 Pandemic Had Minimal Emotional Impact in Progressive MS Patients, Survey Finds I beg to differ. I have secondary progressive MS, and COVID-19 has bummed me out. I haven’t been in an exercise room since May. My wife and I haven’t had a meal in a restaurant since late…

Zeposia (ozanimod) oral capsules continue to safely and effectively prevent relapses and disability progression in people with relapsing forms of multiple sclerosis (MS), according to three-year data from a Phase 3 extension clinical trial. “Gaining insight into long-term therapeutic outcomes can enable clinicians to identify the most appropriate…

FDA Extends Review of Ofatumumab for Relapsing MS to September The U.S. Food and Drug Administration (FDA) was expected to make a decision about ofatumumab, a self-administered injection of a monoclonal antibody, by this month. Now, it looks as if we’ll be waiting until fall. Ofatumumab is already approved…

By my unofficial count, disease-modifying therapy No. 19 has just become available to people with multiple sclerosis in the U.S. The U.S. Food and Drug Administration (FDA) approved Zeposia (ozanimod) in late March. While pharmaceutical companies usually rush to make newly approved medications available to patients, with COVID-19 raging,…

Zeposia (ozanimod), a newly approved oral capsule treatment for relapsing forms of multiple sclerosis (MS), is now commercially available in the United States, its manufacturer, Bristol Myers Squibb, announced. “We are pleased to now bring Zeposia, an important new once daily treatment option, to [relapsing]…

Air Pollution of Urban Life Raises MS Risk, Study from Italy Suggests I grew up in New York City. It’s hard to get more urban than that. There weren’t many factories spewing pollution, but there certainly were a lot of cars, trucks, and buses, and I inhaled more than…

The European Commission (EC) has approved Zeposia (ozanimod) for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) who have active disease based on clinical or imaging features. The EC decision follows a positive opinion issued in March by the European Committee for Medicinal Products for Human Use (CHMP).