June 30, 2022 News by Marisa Wexler, MS Long-term Zeposia May Help Cognitive Function in Patients, Data Show 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. Thatās according to five years of data from the completed SUNBEAM Phase 3 clinical trial (NCT02294058) and the ongoing…
October 8, 2020 News by Marisa Wexler, MS Health Canada Approves Oral Zeposia for Adults With RRMS Health Canada has approvedĀ 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…
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…
May 27, 2020 News by Marisa Wexler, MS Zeposia Receives European Commission Approval for Adults with Active RRMS 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 opinionĀ issued in March by the EuropeanĀ Committee for Medicinal Products for Human Use (CHMP).
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…
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…
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…
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…
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…
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…
February 8, 2018 News by Jose Marques Lopes, PhD #ACTRIMS2018 – Ozanimod Reduces MS Relapses and Brain Deterioration, Phase 3 Trial Shows Celgene’sĀ 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 atĀ theĀ ACTRIMS Forum 2018Ā convention in San Diego, Feb. 1-3. The presentation was titled āOzanimod Demonstrates Efficacy and Safety…
November 15, 2017 News by Patricia Inacio, PhD Ozanimod Superior to Avonex in Treating Relapsing MS in Phase 3 Trials, Celgene Reports Celgene released the results of two Phase 3 trials showing that patients with relapsing multiple sclerosis (MS) who were treated withĀ ozanimod had lowerĀ relapse rates andĀ fewer MRI brain lesions compared to those given a current first-line therapy, AvonexĀ (interferon Ī²-1a). These results will be used to support a request…
May 30, 2017 News by Patricia Inacio, PhD #CMSC17 – Celgene’s Investigational Therapy Ozanimod Safe, Effective in Treating Relapsing MS, Clinical Trial Finds Long-term treatment for up to 12o weeks, with theĀ 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, āEfficacy and Safety of Ozanimod in the Blinded Extension (120…
May 23, 2017 News by Alice MelĆ£o, MSc Results of Phase 3 Trial for Celgene’s Ozanimod Suggest Therapeutic Benefit in RMS Patients Relapsing multiple sclerosis (RMS) patients taking the investigational drug ozanimod, also known as RPC-1063, had lowerĀ relapse rate than those on weekly Avonex (interferon Ī²-1a) therapy, according toĀ CelgeneĀ in an announcement updating results of its Phase 3 RADIANCE trial. Ozanimod is a new orally administrated drug that selectively inhibits the…
February 20, 2017 News by Patricia Silva, PhD Ozanimod Reduces Multiple Sclerosis Relapse Rate, Phase 3 Trial Shows A Phase 3 clinical trial evaluating the safety and effectiveness of ozanimod (RPC-1063) in patients withĀ relapsing multiple sclerosis (RMS)Ā shows treatment reduced the disease’s annualized relapse rate (ARR), researchers reported. The Phase 3 SUNBEAM trial (NCT02294058)Ā testedĀ ozanimod, anĀ oral, selective sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator designed to…
January 21, 2015 News by Patricia Silva, PhD Receptos Launches SUNBEAM Phase 3 Trial for Relapsing Multiple Sclerosis Therapy Biopharmaceutical companyĀ Receptos, Inc. has enrolled the first participantĀ withĀ relapsing multiple sclerosis (RMS) in its SUNBEAM phase 3 trial, which will evaluate the potential therapyĀ RPC1063 in patients who suffer from the disease. The company’s phase 3 RADIANCE trial, also…
December 29, 2014 News by Patricia Silva, PhD Receptos Begins RMS Patient Enrollment in SUNBEAM and RADIANCE Trials Biopharmaceutical company Receptos, Inc. is enrolling the first patient in theirĀ SUNBEAM phase 3 trial to evaluateĀ the company’s investigational therapy for the treatment ofĀ patients with relapsing multiple sclerosis (RMS) and ulcerative colitis (UC), calledĀ RPC1063. In addition, Receptos has recently started its phase 3Ā …