October 22, 2019 News by Joana Carvalho, PhD Long-term Gilenya Treatment Safe and Effective for Relapsing MS Patients, Phase 3 Trial Shows Long-term treatment with Gilenya (fingolimod) in patients with relapsing forms of multiple sclerosis (MS) is safe and effective, results from a Phase 3 trial show. Trial findings were reported in the study, “Extended treatment with fingolimod for relapsing multiple sclerosis: the 14-year LONGTERMS study results,” published in…
September 23, 2019 News by Marisa Wexler, MS EMD Serono Opening Phase 3 Trials of Oral Evobrutinib in Relapsing MS Patients EMD Serono (Merck KGaA in Germany) is opening two pivotal and global Phase 3 clinical trials to evaluate the effectiveness and safety of oral evobrutinibĀ in people with relapsing multiple sclerosis (MS). Evobrutinib, also known as M2951, works by blocking a protein called Brutonās tyrosine kinase (BTK), which is…
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 18, 2019 News by Patricia Inacio, PhD #ECTRIMS2019 – Data Shows Ublituximab’s Long-term Safety in Relapsing MS, TG Therapeutics Announced Ublituximab continues to be safe and well-tolerated by people with relapsing forms of multiple sclerosis (MS) after a median follow-up of 124.7 weeks ā more than 2 years ā according to data from an extension Phase 2 trial. The data were shown in a…
September 17, 2019 News by Ana Pena PhD #ECTRIMS2019 ā Ofatumumab Superior to Aubagio in Lowering Relapse Rates and Lesions, Data Show Monthly under-the-skin injections of ofatumumab are superior to AubagioĀ (teriflunomide) to treat relapsing-remitting multiple sclerosis (RRMS) and secondary progressive multiple sclerosis (SPMS), leading to over 50% reduction in relapse rates, and more than a 90% reduction in active brain lesions, compared with Aubagio, results from ASCLEPIOS I…
September 12, 2019 News by Jose Marques Lopes, PhD #ECTRIMS2019 – No Retinal Thinning with Ocrevus in Relapsing MS Patients, Phase 3 Trials Show Treating relapsing multiple sclerosis (MS) patients with Ocrevus (ocrelizumab) is not associated with retinal thinning ā unlike treatment with Rebif (interferon beta-1a), according to two Phase 3 trials. The findings also showed a link between retinal thinning and brain volume loss. The study, ā…
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 30, 2019 News by Ana Pena PhD Ponesimod Fares Well in Phase 3 Trial for Relapsing MS, Janssen Announces JanssenĀ has announced positive, top-line results from its Phase 3 OPTIMUM study, testing the effectiveness and safety of ponesimod tablets, compared to Sanofi‘s Aubagio (teriflunomide), in adults with relapsing forms of multiple sclerosis (MS). The study met its primary goal ā a reduction in the…
July 23, 2019 News by Patricia Inacio, PhD Gilenya Approved in China for Adults and Children with Relapsing MS Gilenya (fingolimod) has been approved in China as a disease-modifying therapy to treat adults and children, ages 10 and older, with relapsing forms of multiple sclerosis (MS). Gilenya,Ā marketed byĀ Novartis, is an oral disease-modifying treatment for relapsing MS. It acts by binding and modulating receptors…
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 24, 2019 News by Vijaya Iyer, PhD First Patient Dosed in Phase 2B Trial Testing SAR442168 Therapeutic Candidate for RRMS The first patient has been dosed in a Phase 2B clinical trial evaluating the safety, efficacy, and tolerability of SAR442168 in people with relapsing multiple sclerosis (MS). SAR442168, formerly known as PRN2246, is being developed by Principia Biopharma,Ā in collaboration withĀ Sanofi Genzyme, for MS and other central nervous…
May 9, 2019 News by Jose Marques Lopes, PhD #AANAM – Greater Exposure to Ocrevus Means Less Risk of Disability Progression in MS Patients, Study Contends Higher exposure to Ocrevus (ocrelizumab) is associated with greater immune B-cell depletion in the blood, and lessened risk of disability progression in patients with relapsing multiple sclerosis (MS) and primary progressive disease (PPMS), according to new research. The study supporting that finding, āPharmacokinetics, Pharmacodynamics and…
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 27, 2019 News by Patricia Inacio, PhD FDA Approves Novartis’ Mayzent for Relapsing Forms of Multiple Sclerosis, Including Active SPMS The U.S. Food and Drug Administration (FDA) has approved Novartis’ Mayzent (siponimod) oral tablets for adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (CIS), relapsing-remitting disease (RRMS), and active secondary progressive disease (SPMS). Mayzent was designed to inhibit the activity of…
March 20, 2019 News by Jose Marques Lopes, PhD Beta-interferons Extend Survival of Relapsing MS Patients, Study Reports Treatment of relapsing multiple sclerosis (MS) with beta-interferon therapies is associated with extended patient survival, particularly if taking such treatments for more than three years, according to a real-world study in Canada and France. The study, āMultiple sclerosis: effect of beta interferon treatment on survival,ā was…
March 15, 2019 News by Jose Marques Lopes, PhD #AANAM – Ublituximab Safe, Well-tolerated in Extension Study of Phase 2 Trial in Relapsing MS Treatment withĀ ublituximab continues to be safe and well-tolerated by patients with relapsing forms of multiple sclerosis, according to an extension study of a Phase 2 trial. According to a press release, Edward Fox, MD, PhD, from Central Texas Neurology Consultants, will give the presentation on May 7 at poster session P3: MS Clinical Trials and Therapeutic Research. Ublituximab is an investigational monoclonal antibody being developed by TG Therapeutics to target the immune B-cell marker protein CD20. This leads to the depletion of B-cells from the blood and central nervous system ā B-cells are activated during MS relapses. According to the company, ublituximab may be superior to current anti-CD20 treatments in MS, enabling both lower doses and shorter infusion times. Final results of the main TG-Therapeutics-sponsored Phase 2 trial were recently presented at the 4thĀ Annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum, held in Dallas, Texas. Data showed that 93% of the 48 patients enrolled (mean age 40 years) were relapse-free after a 48-week treatment with ublituximab. The annualized relapse rate ā the number of relapses per year ā was 0.07. In addition, median B-cell depletion was more than 99% throughout 48 weeks.Ā Moreover, 87% of participants showed no evidence of clinical disease. Magnetic resonance imaging showed a complete elimination of T1 lesions at 24 and 48 weeks 24 in all 46 patients analyzed. Mean T2 lesion volume decreased by 10.6% at 48 weeks, compared with the beginning of the study. T1 lesions refer to areas of active inflammation and disease activity, while T2 lesions are a measure of the total amount of lesions, both old and new. Ublituximab was found to be well-tolerated, and did not induce an severe treatment-related adverse events. The most frequent adverse events were infusion-related reactions. No patient had to discontinue treatment due to an ublituximab-related side effect. At the upcoming AAN meeting, Fox will present data on both this Phase 2 trial andĀ its open-label extension, in which 37 patients from the primary study continued receiving one-hour infusions of 450 mg of ublituximab every 24 weeks for an additional 96 weeks. Safety was monitored throughout the study, and disability assessments using theĀ Expanded Disability Status ScaleĀ were conducted every 48 weeks. As of October 2018, nearly 30% of participants had completed 48 weeks of treatment in the extension study. Results showed that ublituximab continues to be well-tolerated, with no discontinuations due to adverse events. āThe Phase 2 OLE supports that one-hour infusions of [ublituximab] continue to be safe and well tolerated,ā the researchers wrote. Of note, five of the eight study authors are affiliated with TG Therapeutics. The team expects additional patient follow-up data from the study to be available by the time of the AAN presentation. According to the scientists, the results support the ongoing Phase 3 ULTIMATE program, which includes the ULTIMATE 1 and ULTIMATE 2 trials. These studies are comparing the efficacy and safety of 450 mg of ublituximab withĀ AubagioĀ over 96 weeks of treatment in relapsing MS patients.Ā Both trials are led byĀ Lawrence Steinman, MD, atĀ Stanford University. TG Therapeutics expects toĀ have results from these trials as early as mid-2020.
February 27, 2019 News by Alice MelĆ£o, MSc FDA Will Review New Drug Application of Diroximel Fumarate for Relapsing Forms of MS The U.S. Food and Drug Administration (FDA) has agreed to review Alkermesā request to approve diroximel fumarate (BIIB098) as a treatment for relapsing forms of multiple sclerosis (MS), the company announced. A final decision by the FDA is expected in the fourth quarter of 2019. If approved, diroximel…
January 23, 2019 News by Jose Marques Lopes, PhD Favorable Efficacy and Similar Safety with Ocrevus in Relapsing MS, Study Finds Treatment with Ocrevus (ocrelizumab) has superior or comparable effectiveness and a similar safety profile to other available disease-modifying treatments (DMTs) for treating relapsing multiple sclerosis (MS), according to a new review study. The research, āSystematic review and network meta-analysis comparing ocrelizumab with other treatments for…
November 27, 2018 Columns by Ed Tobias FDA Warns of Possible Dangers of Stopping Gilenya If you are being treated with Gilenya, take note. The U.S. Food and Drug Administration is warning that if you stop using Gilenya (fingolimod), there’s a chance your MS could become worse. The FDA issued a safety alert saying that this only happens rarely, but when it does, the…
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…
September 5, 2018 News by Alice MelĆ£o, MSc Mavenclad Approved to Treat Highly Active Relapsing MS Patients in Ireland Adults in Ireland with highly active relapsing multiple sclerosis (MS) now can be treated with Mavenclad (cladribine tablets, 10 mg), the first short-course oral treatment approved for this disease. The Irish Health Service Executive (HSE) has approved this new therapy and decided to reimburse patients for its associated…
August 10, 2018 News by Iqra Mumal, MSc TG Therapeutics Reaches Target Enrollment in Phase 3 Trials to Test Ublituximab in Relapsing MS TG Therapeutics announced it has reached target enrollment in the ULTIMATE I and II Phase 3 clinical trials assessing the use of ublituximab (TG-1101) to treat relapsing forms of multiple sclerosis (MS). Ublituximab is a modified anti-CD20 monoclonal antibody, which is designed to target a protein present onĀ mature…
July 31, 2018 News by Alice MelĆ£o, MSc FDA to Review EMD Serono’s New Request for Approval of Cladribine for Treating Relapsing MS Seven years after it first denied the request, the U.S. Food and Drug Administration accepted for review EMD Seronoās resubmitted New Drug Application (NDA) for cladribine tabletsĀ (brand name Mavenclad) as a treatment for patients with relapsing forms of multiple sclerosis (MS). The regulatory agency agreed EMD…
June 19, 2018 News by Alice MelĆ£o, MSc #EAN2018 ā Ocrevus Lowers Relapse Rates Over Long Term and Better Than Rebif Does, Data Show Long-term treatment with Ocrevus (ocrelizumab) Ā ā as well as switching from Rebif (interferon beta-1a) to Ocrevus ā leads to a significant and sustained reduction in disease activity in relapsing forms of multiple sclerosis (MS). TheseĀ previouslyĀ reportedĀ findingsĀ are further supported by the latest results drawn from pooled data…
May 3, 2018 News by Alice MelĆ£o, MSc Mavenclad Effective in Treating Highly Active MS, New CLARITY Analysis Shows An additional analysis of data from the CLARITY study confirmed the long-term benefits of treatment with Mavenclad (cladribine tablets) for patients with highly active relapsing forms of multiple sclerosis (MS). The post-hoc analysis, āEfficacy of Cladribine Tablets in high disease activity subgroups of patients…
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…
April 11, 2018 News by Alice MelĆ£o, MSc Mavenclad Approved by United Arab Emirates to Treat Highly Active Relapsing MS The United Arab Emirates is the first country in the Middle East and Africa to approve Mavenclad (cladribine tablets) as a treatment for patients with highly active relapsing multiple sclerosis (MS) evidenced through imaging tests or clinical evaluation. The therapy is expected to become available once local regulatory…
March 6, 2018 News by Jose Marques Lopes, PhD Biogen and AbbVie Voluntarily Withdraw Marketing Authorizations for MS Therapy Zinbryta BiogenĀ and AbbVieĀ have voluntarily withdrawn global marketing authorizations for theirĀ relapsing multiple sclerosisĀ therapyĀ Zinbryta (daclizumab) because of serious side effects that include brain inflammation. The Europe Medicine Agency, which oversees medications across the European Union, also released a statement recommending a “immediate suspension” of Zinbryta’s use by patients and…
March 2, 2018 News by Alice MelĆ£o, MSc FDA Wants More Information on Celgene’s MS Therapy Ozanimod Before Starting Its Review The U.S. Food and Drug Administration has asked CelgeneĀ to add more information to its New Drug Application for ozanimod as a treatment for relapsing forms of multiple sclerosis. Celgene said it plans to meet with FDA officials to make sure it understands exactly what new information the agency…
March 1, 2018 News by Alice MelĆ£o, MSc Argentina Approves Mavenclad for Active Relapsing MS Argentina has become the first country in Latin America to approve MavencladĀ (cladribine) as a treatment for adults with highly active relapsing multiple sclerosis. The Argentinian Administration of Medicines, Food and Medical Technology's approval coveredĀ Merckās cladribine tablet formulation. Merck expects to make the treatment available in the country in the next few months. Mavenclad has already been approved in Canada, Australia, Israel, and Europe. Merck is seeking approval in the United States and other countries. "Having a new MS treatment approved in Argentina is very motivating," Dr. Jorge Correale of the Institute for Neurological Research Dr. RaĆŗl Carrea said in a press release. "Mavenclad allows the patient's immune system to go through a selective immune reconstitution, similar to a reset, and the treatment mechanism is simple because it does not require frequent administration or monitoring," said Correale,Ā head of the institute's neuroimmunology and demyelinating diseases department. Mavenclad is designed to target the immune T- and B-cells that trigger relapsing MSĀ without suppressing the entire immune system. With a maximum of 20 days' treatment over two years, the oral drug promotes long-term inhibition of harmful immune cells, reconstituting the immune system. MS is an autoimmune disease, or one in which the immune system attacks normal tissue as well as invadors. Argentine regulators based their approval on the results of five clinical trials. These were the Phase 3 CLARITY, CLARITY EXTENSION, and ORACLE-MS studies, the Phase 2 ONWARD study, and the long-term PREMIERE study. These trials involved more than 2,700Ā patients with relapsing MS, some of whom researchers followed for more than 10 years. The trials showed that Mavenclad can significantly reduce MS relapse rates, disability progression and brain atrophy. The treatment is recommended for patients who fail to respond adequately, or are unable to tolerate, other therapies. "We are pleased the Argentinian Administration of Medicines, Food and Medical Technology has approved Mavenclad," said Rehan Verjee, the chief marketing and strategy officer of Merck's biopharma business. "Our goal is to ensure fast access to patients who may benefit from this innovative therapy, and we will be working with payers on obtaining reimbursement as a next step."