Celgene

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…

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…

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 …

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…

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]…

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…

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…

Ozanimod — an investigational oral therapy up for approval to treat relapsing multiple sclerosis (MS) — 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…

The MS MindShift: A New View of MS initiative is continuing its travels to raise awareness and educate people about brain health in multiple sclerosis (MS), with the next stop for its “Brain Bulb” hot air balloon the Owl-O-Ween Hot Air Balloon Festival in Kennesaw, Georgia. This weekend’s event, Oct. 18–19,…

Celgene‘s oral ozanimod, if approved, 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…

Oral ozanimod is more effective at reducing the frequency of relapses than 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…

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 37th Annual QuickChek New Jersey Festival of Ballooning in Readington,…

Kinza Kasher from LeoPlus USA was selected from a list of 10 finalists to receive the $25,000 grant for “Addressing Unmet Needs in MS: An Innovation Challenge,” Lyfebulb and Celgene announced. This initiative’s goal is to encourage the development of innovative solutions to help those…

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…

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) both agreed to review for possible approval ozanimod, Celgene‘s investigational oral therapy for relapsing forms of multiple sclerosis (MS). An FDA decision on the company’s New Drug Application for ozanimod is expected on…

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…

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).  The Lyfebulb-Celgene 2019 “Addressing Unmet Needs in MS: An Innovation Challenge,” will take…

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…

An application has been submitted to approve ozanimod as an oral treatment for adults with relapsing forms of multiple sclerosis in the U.S., according to its developer, Celgene. “New oral treatment options with differentiated profiles like ozanimod are needed to help address an unmet need for people with relapsing forms of MS,” Jay Backstrom, MD, Celgene’s chief medical officer, said in a press release. Celgene's New Drug Application has been submitted to the U.S. Food and Drug Administration. Earlier this month, the company submitted a marketing authorization application to the European Medicines Agency covering the treatment of adults with relapsing-remitting MS. “With 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,” Backstrom said. Ozanimod is designed to cause the retention of immune cells in lymphoid tissues, thereby blocking their migration to the central nervous system — brain and spinal cord — 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 called SUNBEAM and RADIANCE part B. Both studies demonstrated that ozanimod reduced the number of relapses and brain lesions. In the SUNBEAM Phase 3 trial, 1,346 participants with relapsing MS were randomized to one daily dose of 0.92 or 0.46 mg of ozanimod — equivalent to 1 mg and 0.5 mg of the therapy’s HCI formulation — or Avonex (interferon beta-1a, marketed by Biogen) for at least 12 months. Results showed that treatment with ozanimod led to fewer relapses 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 study included an increased percentage of patients free of T1 lesions on MRI (magnetic resonance imaging) scans — which refer to areas of active inflammation and disease activity — after two years of treatment, from 58.5–69.0% of patients in part A to 86.5–94.6% of patients in part B. T2 lesions, a measure of the total amount of MRI lesions — both old and new — 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 ozanimod’s benefits using 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 — the number of relapses per year — 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.

An application has been submitted for the use of ozanimod to treat adult patients with relapsing-remitting multiple sclerosis (RRMS) within the European Union, according to Celgene, the developer of ozanimod. The marketing authorization application was submitted to the European Medicines Agency…

A collaborative initiative between Lyfebulb and Celgene — called “Addressing Unmet Needs in MS: An Innovation Challenge” — 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…

Lyfebulb announced that it has joined with Celgene in launching an innovation challenge for entrepreneurs with or impacted by multiple sclerosis (MS) to develop user-driven solutions that might make daily life a little easier for patients. The initiative, “Addressing Unmet Needs in MS: An Innovation Challenge,” will be…

Although brain atrophy — the loss of brain volume — is an increasingly important measure in multiple sclerosis trials and treatment outcomes, MS patients have a limited understanding of its role in disease progression, a survey reveals. This finding was detailed in the presentation “…

Additional analysis of clinical data from Celgene’s 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…

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 “Increased risk of…

Being treated with 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 to ozanimod from placebo. Results…

Celgene’s 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…

Since Genentech‘s Ocrevus was approved a year ago, the treatment rate of primary progressive multiple sclerosis (PPMS) 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 by Spherix Global Insights in their new study…