RADIANCE

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…

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…

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).

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…

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…

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…

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 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…

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…

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…

Celgene’s Ozanimod reduces relapsing multiple sclerosis patients’ relapses, brain lesions, and brain volume loss, a Phase 3 clinical trial shows. The company presented the results of the SUNBEAM trial at the ACTRIMS Forum 2018 convention in San Diego, Feb. 1-3. The presentation was titled “Ozanimod Demonstrates Efficacy and Safety…

Celgene released the results of two Phase 3 trials showing that patients with relapsing multiple sclerosis (MS) who were treated with ozanimod had lower relapse rates and fewer MRI brain lesions compared to those given a current first-line therapy, Avonex (interferon β-1a). These results will be used to support a request…

Celgene‘s investigative drug ozanimod has been shown to be more efficient than an intramuscular injection of interferon beta-1a (marketed as Avonex by Biogen) in reducing relapses and disease progression in patients with relapsing multiple sclerosis (MS), according to results of the two-year Phase 3 RADIANCE trial. The findings were…

Long-term treatment for up to 12o weeks, with the investigational drug Ozanimod (RPC-1063), found to be effective and safe in patients with relapsing multiple sclerosis (MS) who participated in the RADIANCE clinical trial. Celgene, Ozanimod’s developer, presented the study, “Efficacy and Safety of Ozanimod in the Blinded Extension (120…

Relapsing multiple sclerosis (RMS) patients taking the investigational drug ozanimod, also known as RPC-1063, had lower relapse rate than those on weekly Avonex (interferon β-1a) therapy, according to Celgene in an announcement updating results of its Phase 3 RADIANCE trial. Ozanimod is a new orally administrated drug that selectively inhibits the…

A Phase 3 clinical trial evaluating the safety and effectiveness of ozanimod (RPC-1063) in patients with relapsing multiple sclerosis (RMS) shows treatment reduced the disease’s annualized relapse rate (ARR), researchers reported. The Phase 3 SUNBEAM trial (NCT02294058) tested ozanimod, an oral, selective sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator designed to…

Results from the extension period of a Phase 2 trial, assessing ozanimod as a potential treatment for relapsing-remitting multiple sclerosis, showed that the drug can effectively and safely improve clinical measures of RRMS after two years of treatment. The announcement was made by Celgene International Sàrl, a subsidiary of Celgene Corporation,…

Celgene Corporation announced the results from an extension study of the RADIANCE Phase 2 clinical trial evaluating ozanimod in patients with relapsing multiple sclerosis (MS). The results were also presented at the recent Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2016 in New Orleans, Louisiana. Ozanimod is a small…

Biopharmaceutical company Receptos, Inc. has enrolled the first participant with relapsing multiple sclerosis (RMS) in its SUNBEAM phase 3 trial, which will evaluate the potential therapy RPC1063 in patients who suffer from the disease. The company’s phase 3 RADIANCE trial, also…

Biopharmaceutical company Receptos, Inc. is enrolling the first patient in their SUNBEAM phase 3 trial to evaluate the company’s investigational therapy for the treatment of patients with relapsing multiple sclerosis (RMS) and ulcerative colitis (UC), called RPC1063. In addition, Receptos has recently started its phase 3 …

Biopharmaceutical company Receptos, Inc. announced that they will review data from the phase 2 portion of the RADIANCE trial, the company’s phase 2 / 3 study testing RPC1063 in the treatment of Relapsing Multiple Sclerosis (RMS). The data is being presented at the largest meeting dedicated to multiple sclerosis…

Following the promising results of prior trials, Receptos, Inc., a biopharmaceutical company engaged in the treatment of immune and metabolic diseases, announced that the Phase 2 portion of the RADIANCE trial has met the primary endpoint, a reduction in MRI brain lesion activity in patients with relapsing multiple sclerosis…