Zeposia

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…

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.

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 …

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).

Zeposia’s recent approval in the U.S. is exciting news for all in the MS community. Unfortunately, we will need to table that excitement a bit longer. Despite its approval, the treatment’s commercial distribution will be delayed by the COVID-19 pandemic. I am confident, however, that it will be…

The Committee for Medicinal Products for Human Use (CHMP) has recommended Zeposia (ozanimod) oral capsules to be approved in the European Union (EU) to treat adults with active relapsing-remitting multiple sclerosis (RRMS). Opinions released by CHMP, an arm of the European Medicines Agency (EMA), are generally accepted by the European Commission,…

The U.S. Food and Drug Administration (FDA) has approved Zeposia (ozanimod) oral capsules to treat adults with relapsing forms of multiple sclerosis (MS), including relapsing-remitting MS (RRMS),  active secondary progressive MS (SPMS), and clinically isolated syndrome (CIS). Due to the COVID-19 pandemic, however, when it will arrive in clinics…

Lead scientists representing Biogen and AbbVie presented new data on clinical results from the Phase 3 study DECIDE on the compound ZINBRYTA TM at the 31st Congress of the European Committee for Treatment and Research in MS (ECTRIMS) in Barcelona, Spain. The full results of the 2 to 3-year long…

The U.S. Food and Drug Administration (FDA) has announced it will consider marketing approval of ZINBRYTA (daclizumab high-yield process), a potential treatment for relapsing forms of multiple sclerosis (MS). Biogen and AbbVie, who are jointly developing the therapy, have filed a Biologics License Application…