May 17, 2021 News by Patricia Inacio, PhD NICE Again Says No to Adding Zeposia to Health System for England and Wales 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…
February 9, 2021 News by Marisa Wexler, MS Zeposia Tablets Approved in Scotland to Treat Active RRMS The Scottish Medicines Consortium (SMC) has approvedĀ Zeposia (ozanimod)Ā 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…
January 25, 2021 News by Joana Carvalho, PhD NICE Opposes Zeposia Being Added to RRMS Therapies in UK’s Health Service 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)Ā living in England and Wales. In a recentĀ draft recommendation, NICE stated thatĀ …
September 3, 2020 News by Marta Figueiredo, PhD #MSVirtual2020 ā Zeposia Still Prevents Relapses in Relapsing MS Patients After 3 Years, Trial Data Show 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. āGaining insight into long-term therapeutic outcomes can enable clinicians to identify the most appropriate…
June 3, 2020 News by Marisa Wexler, MS Zeposia, Daily Oral Treatment for Relapsing MS, Now Available in US ZeposiaĀ (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,Ā announced. “We are pleased to now bring Zeposia, an important new once daily treatment option, to [relapsing]…
April 9, 2020 Columns by Jennifer (Jenn) Powell Zeposia Is Now Approved, But Expect Delays 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…
March 30, 2020 News by Marta Figueiredo, PhD CHMP Favors Zeposia (Ozanimod) as Oral Treatment for Active RRMS in EU TheĀ Committee for Medicinal Products for Human UseĀ (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 theĀ European Medicines AgencyĀ (EMA), are generally accepted by the European Commission,…
March 26, 2020 News by Marta Figueiredo, PhD FDA Approves Zeposia (Ozanimod), Oral Therapy for All with Relapsing MS The U.S. Food and Drug Administration (FDA) has approved ZeposiaĀ (ozanimod) oral capsules to treat adults with relapsing forms ofĀ multiple sclerosisĀ (MS), includingĀ relapsing-remitting MS (RRMS), Ā active secondary progressive MS (SPMS), and clinically isolated syndromeĀ (CIS). Due to the COVID-19 pandemic, however, when it will arrive in clinics…
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 3, 2020 News by Ana Pena PhD #ACTRIMS2020 – Ozanimod May Ease Inflammation While Retaining Some Immune Defenses Ozanimod ā an investigational oral therapy up for approval to treat relapsing multiple sclerosis (MS) ā lowers the number of white blood cells circulating in the blood, supporting its ability to ease inflammation in the brain and spinal cord. But this treatment also does not affect all…
October 18, 2019 News by Alice MelĆ£o, MSc MS Mindshift Brings Brain Health Effort, ‘Brain Bulb’ Hot Air Balloon to Atlanta Area Festival The MS MindShift: A New View of MSĀ initiative is continuing its travels to raise awareness and educate people about brain health in multiple sclerosis (MS), with the next stop for its āBrain Bulbā hot air balloon the Owl-O-Ween Hot Air Balloon FestivalĀ in Kennesaw, Georgia. This weekend’s event, Oct. 18ā19,…
September 18, 2019 News by Ana Pena PhD #ECTRIMS2019 – Ozanimod’s ‘Key Advantages’ May Lead to New First-line MS Therapy: Interview with Neurologist Jeffrey Cohen Celgene‘s oralĀ ozanimod, if approved,Ā could be a first-line oral treatment option for people with relapsing multiple sclerosis (MS), and one with relatively minor side effects. Recent results from the Phase 3 trials RADIANCE (NCT02047734) and…
September 6, 2019 News by Joana Carvalho, PhD Oral Ozanimod More Effective Than Avonex in Lowering Annual Relapses in MS Patients, Phase 3 Trial Finds Oral ozanimodĀ is more effective at reducing the frequency of relapses thanĀ Avonex (interferon beta-1a) in patients with relapsing forms of multiple sclerosis (MS), and does so with reasonable safety, results of Phase 3 trial show. These findings were described in the study, “Safety and efficacy of ozanimod…
July 26, 2019 News by Joana Carvalho, PhD MS MindShift Campaign Uses Balloon Festival to Raise Awareness About MS Brain Health Celgene and the Multiple Sclerosis Association of America (MSAA) are working together to bring the “MS MindShift: A New View of MS” campaign, which is raising awareness about the importance of brain health in multiple sclerosis (MS), to the 37thĀ AnnualĀ QuickChek New Jersey Festival of Ballooning in Readington,…
June 19, 2019 News by Alice MelĆ£o, MSc Duet, an Innovative Device and App, Wins Lyfebulb-Celgene 2019 MS Innovation Challenge Kinza Kasher from LeoPlus USA was selected from a list of 10 finalists to receive the $25,000 grant for āAddressing Unmet Needs in MS: An Innovation Challenge,ā Lyfebulb and Celgene announced. This initiative’s goal is to encourage the development of innovative solutions to help those…
June 10, 2019 Columns by Ed Tobias MS News That Caught My Eye Last Week: Ozanimod for RRMS, MS Monitoring App, Video Series FDA and EMA to Review Ozanimod as Possible Oral Therapy for Relapsing MS Another disease-modifying therapy (DMT) is a step closer to gaining approval for use both in the U.S. and in Europe. And that’s good news. The discouraging news, however, is that once again, the approval is being…
June 7, 2019 News by Joana Carvalho, PhD FDA and EMA to Review Ozanimod as Possible Oral Therapy for Relapsing MS The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) both agreed to review for possible approvalĀ ozanimod, Celgene‘s investigational oral therapy for relapsing forms of multiple sclerosis (MS). An FDA decision on the company’sĀ New Drug Application for ozanimod is expected on…
May 29, 2019 News by Marisa Wexler, MS Celgene and MS Association of America Collaborating to Boost Knowledge on Brain Health in MS Biopharmaceutical company Celgene has teamed up with the Multiple Sclerosis Association of America (MSAA) to launch a new initiative called MS MindShift: A New View of MS, aimed at educating the multiple sclerosis (MS) community on brain health. Although it’s an “important topic,” brain health “is not…
May 17, 2019 News by Joana Carvalho, PhD Lyfebulb and Celgene Announce 2019 Innovation Challenge Finalists Lyfebulb and Celgene have announced the 10 finalists who will compete for a $25,000 grant to support the development of their innovative proposals that address an unmet need in multiple sclerosis (MS).Ā The Lyfebulb-Celgene 2019 “Addressing Unmet Needs in MS: An Innovation Challenge,” will take…
May 10, 2019 News by Ana Pena PhD #AANAM – Oral Ozanimod Better than Avonex in Lessening Brain Volume Loss in Relapsing MS, Trial Shows Oral treatment with ozanimod (RPC1063), an investigational immunomodulator under development by Celgene, is better at preventing brain volume loss, compared with Avonex (interferon-beta-1a), in adults with relapsing forms of…
March 27, 2019 News by Jose Marques Lopes, PhD Celgene Seeking FDA Approval for Ozanimod to Treat Adults With Relapsing MS An application has been submitted to approveĀ ozanimod as an oral treatment for adults with relapsing forms of multiple sclerosis in the U.S., according to its developer,Ā Celgene. āNew oral treatment options with differentiated profiles like ozanimod are needed to help address an unmet need for people with relapsing forms of MS,ā Jay Backstrom, MD, Celgeneās chief medical officer, said in a press release. Celgene'sĀ New Drug Application has been submitted to the U.S. Food and Drug Administration. Earlier this month, the companyĀ submitted a marketing authorization application to the European Medicines Agency covering the treatment of adults with relapsing-remitting MS. āWith concurrent applications in the U.S. and EU, we look forward to advancing this promising medicine through the regulatory review process to provide a new option for the treatment of (relapsing MS) in 2020,ā Backstrom said. Ozanimod is designed to cause the retention of immune cells in lymphoid tissues, thereby blocking their migration to the central nervous system ā brain and spinal cord ā and preventing damage to nerve fibers and their protective layer, called myelin. The investigational therapy selectively binds to S1P receptor subtypes S1P1 and S1P5. The NDA application is based on positive findings from two multicenter, double-blind, Phase 3 trials calledĀ SUNBEAM andĀ RADIANCE part B. Both studies demonstrated that ozanimod reduced the number of relapses and brain lesions. In theĀ SUNBEAMĀ Phase 3 trial, 1,346 participants with relapsing MSĀ were randomized to one daily dose of 0.92 or 0.46 mg of ozanimod ā equivalent to 1 mg and 0.5 mg of the therapyās HCI formulation ā orĀ AvonexĀ (interferon beta-1a, marketed byĀ Biogen) for at least 12 months. Results showed that treatment with ozanimod led toĀ fewer relapsesĀ and brain lesions, as well as clinically meaningful improvements in processing speed compared with Avonex. In the Phase 2/3 RADIANCE trial, patients were divided in two parts: in part A, participants received either one daily dose of ozanimod (0.5 mg or 1.0 mg) or a placebo for 24 weeks; in part B, a 96-week open-label extension study completed by 223 patients, those initially on placebo switched to ozanimod. As in the SUNBEAM trial, results of part A of the RADIANCE trial revealed a reduction in the number of brain lesions from weeks 12 to 24, as well as less frequent relapses compared with a placebo. Treatment with ozanimod was safe and well-tolerated. Findings of part B of the studyĀ included an increased percentage of patients free of T1 lesions on MRI (magnetic resonance imaging) scans ā which refer to areas of active inflammation and disease activity ā after two years of treatment, from 58.5ā69.0% of patients in part A to 86.5ā94.6% of patients in part B. T2 lesions, a measure of the total amount of MRI lesions ā both old and new ā and relapse rate remained low in patients maintained on ozanimod (more significantly with the higher dose of 1.0 mg), and dropped in those who switched from a placebo. The scientists also analyzed ozanimodās benefits usingĀ data from the SUNBEAM and RADIANCE part B trials, which covered 2,659 patients treated over one to two years. Compared with Avonex, ozanimod reduced the annualized relapse rates ā the number of relapses per year ā by 42% in the higher dose group and 26% in the lower dose group. Treatment with ozanimod also lessened the relapse rate requiring steroid treatment or hospitalization by 43% (in the 1 mg dose group) and 26% (in the 0.5 mg dose group) compared with Avonex treatment. In addition to MS, ozanimod is also being developed for patients with ulcerative colitis and Crohn's disease, two inflammatory bowel diseases.
March 12, 2019 News by Jonathan Grinstein Celgene Seeks Approval in European Union for Ozanimod to Treat Adult RRMS An application has been submitted for the use of ozanimod to treat adult patients withĀ relapsing-remitting multiple sclerosis (RRMS)Ā within the European Union, according toĀ Celgene, the developer of ozanimod. The marketing authorization application was submitted to the European Medicines Agency…
February 7, 2019 News by Vijaya Iyer, PhD Innovation Challenge Invites Applications from Entrepreneurs Affected by MS A collaborative initiative betweenĀ LyfebulbĀ andĀ CelgeneĀ ā called “Addressing Unmet Needs in MS: An Innovation Challenge” ā is inviting applications from U.S.-based entrepreneurs who have multiple sclerosis (MS), or who have been affected by the disease, and whose companies are trying to find solutions to address unmet needs…
November 16, 2018 News by Vijaya Iyer, PhD Celgene and Lyfebulb Partner on ‘Innovation Challenge’ for Entrepreneurs Affected by MS Lyfebulb announced that it has joined with Celgene in launching an innovation challenge for entrepreneurs with or impacted byĀ multiple sclerosisĀ (MS) to develop user-driven solutions that might make daily life a little easier forĀ patients. The initiative, āAddressing Unmet Needs in MS: An Innovation Challenge,ā will be…
October 18, 2018 News by Alice MelĆ£o, MSc #ECTRIMS2018 – Role of Brain Atrophy in MS Progression Poorly Understood by Patients, MSAA Survey Finds Although brain atrophy ā the loss of brain volume ā is an increasingly important measure in multiple sclerosis trials and treatment outcomes, MS patients have a limited understanding of its role in disease progression,Ā a survey reveals. This finding was detailed in the presentation ā…
October 15, 2018 News by Alice MelĆ£o, MSc #ECTRIMS2018 ā Additional Analysis on Ozanimod Demonstrates Its Potential to Treat Relapsing MS Additional analysis of clinical data from Celgeneās investigational agent ozanimod continues to demonstrate its potential to benefit patients with relapsing multiple sclerosis (MS). Findings from the Phase 3 SUNBEAM and RADIANCE Part B trials were discussed at the 34th Congress of the European Committee for Treatment and…
October 12, 2018 News by Alice MelĆ£o, MSc #ECTRIMS2018 – MS Patients More Prone to Health Problems Before, After Diagnosis, Study Suggests Patients with multiple sclerosis (MS) are more likely to experience health problems before they receive their formal diagnosis, as well as to experience serious non-MS-related complications after diagnosis, a study reveals. The findings were reported in the study āIncreased risk of…
August 1, 2018 News by Marta Figueiredo, PhD Ozanimod Effectively Lowers Relapse Rates in MS Patients, Data from 2-Year Extension Study Show Being treated withĀ ozanimod consistently reduced disease activity in people with relapsing-remitting multiple sclerosis (RRMS), according to results of a two-year extension of a Phase 2 trial. These benefits were evident both in patients on continuous treatment throughout the study, and in those who switched toĀ ozanimod from placebo. Results…
April 24, 2018 News by Alice MelĆ£o, MSc #AAN2018 ā Celgene to Present Latest Data on Ozanimod’s Safety and Effectiveness Celgeneās oral treatment candidate ozanimod can effectively reduce relapse rates in multiple sclerosis (MS) patients with mild to moderate disability, results of two Phase 3 trials show. The company will present data on the SUNBEAM (NCT02294058) and RADIANCE (NCT02047734) trials in two presentations at the…
March 15, 2018 News by Patricia Inacio, PhD New Spherix Report Finds PPMS Treatment Increased Significantly in Past Year Since Genentech‘sĀ OcrevusĀ was approvedĀ a year ago, the treatment rate of primary progressive multiple sclerosis (PPMS)Ā has increased significantly. However, a closer look at the data shows that other disease-modifying therapies (DMTs) are equally responsible for this increase. The findings were reported byĀ Spherix Global InsightsĀ in their new study…