May 23, 2018 News by Diogo Pinto European EMA Confirms Severe Risks Associated with MS Medicine Zinbryta A review of data concerning the multiple sclerosis (MS) medicine Zinbryta (daclizumab) confirmed its association with the risk of developing severe and potentially fatal immune reactions in the brain, liver and other organs, according to the European Medicines Agency’s (EMA)ās Pharmacovigilance Risk Assessment Committee (PRAC). Zinbryta was authorized…
April 12, 2018 Columns by Tamara Sellman The MS Alphabet: UTI, Vertigo, White Matter Lesions, and Other ‘U’ Through ‘Z’ Terms Editorās note: Tamara Sellman continues her series on the “MS alphabet” with this column referencing terms starting with the letters “U” through “Z.” This is the last post in this series.Ā Symptoms of MS Uhthoff’s phenomenon People with MS are often heat-sensitive and experience overheating due to…
March 12, 2018 Columns by Ed Tobias MS News that Caught My Eye Last Week: Zinbryta, Fish Oil, MS Associate Certification, Blood-brain Barrier Biogen and AbbVie Voluntarily Withdraw Marketing Authorizations for MS Therapy Zinbryta You may have heard about this already, so forgive me if it’s not new to you, but it’s important information. A dozen cases ofĀ encephalitis or meningoencephalitis have been reported in patients using Zinbryta, and…
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and AbbVie Voluntarily Withdraw Marketing Authorizations for MS Therapy Zinbryta BiogenĀ and AbbVieĀ have voluntarily withdrawn global marketing authorizations for theirĀ relapsing multiple sclerosisĀ therapyĀ Zinbryta (daclizumab) because of serious side effects that include brain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…
December 28, 2017 News by Patricia Inacio, PhD Zinbryta Fails to Prevent RRMS from Worsening After Patient Gets Off Tysabri, Case Study Shows Zinbryta (daclizumab) may not be the best follow-up therapy for relapsingāremitting multiple sclerosis patients who stop taking Tysabri (natalizumab) for safety reasons, a case study suggests. An article on the 25-year-old patient’s case, titled āDisease reactivation after switching from natalizumab to daclizumab,ā was published in…
July 11, 2017 News by Patricia Silva, PhD Europe Restricts Use of MS Therapy Zinbryta After Liver Damage Cases and a Death The European Medicines Agency has restricted the use of Zinbryta (daclizumab) for relapsing multiple sclerosis after reports of patients experiencing severe liver damage and one dying of liver disease. The temporary order restricts Zinbryta to European Union patients with a highly active disease who have failed to respond to…
April 13, 2017 News by Alice MelĆ£o, MSc Scottish Medicines Consortium Approves Zinbryta for NHS Treatment of RRMS Patients in Scotland The United KingdomāsĀ National Institute for Health and Care Excellence (NICE)Ā last month recommendedĀ Zinbryta (daclizumab)Ā to treatĀ relapsing-remitting multiple sclerosis (RRMS)Ā in England and Wales. On April 10,Ā Scotland receivedĀ Scottish Medicines Consortium (SMC)Ā approval for the National Health Service (NHS) to prescribe ZinbrytaĀ as a treatment for RRMS. Zinbryta is…
March 17, 2017 News by Patricia Silva, PhD In Reversal, NICE Recommends Relapsing MS Treatment Zinbryta for England and Wales The United Kingdom’sĀ National Institute for Health and Care Excellence (NICE) has cleared its initial doubts and now recommendsĀ Zinbryta (daclizumab)Ā to treatĀ relapsing multiple sclerosis (MS) in England and Wales. NICE had initially rejectedĀ Zinbryta after a first stage of the drugās review process, due to some issues linked to…
March 16, 2017 Columns by admin After Long Wait, Zinbryta Gains Approval in Areas of the UK News that daclizumab, brand name Zinbryta, has been given the go-aheadĀ to be available through the U.K.ās National Health Service (NHS) for treating relapsing MS, at least in part of the country, is good news. But why has the decision taken…
February 6, 2017 News by Patricia Inacio, PhD Researchers Identify Gene Regions with High Levels of Proteins Linked to MS A genome-wide study has identified DNA regions associated with higher levels of circulating cytokines, small proteins that pay aĀ role in inflammatory diseases such as multiple sclerosis (MS). Alterations in the levels and interplay of cytokines and growth factors play a key role in several inflammatory diseases, including MS.Ā Cytokines help regulate…
January 31, 2017 News by Patricia Silva, PhD Patient Opinions on Zinbryta Seen to Match Phase 3 Trial Data, Supporting Questionnaire Use More relapsing multiple sclerosis (MS) patients treated withĀ Zinbryta (daclizumab)Ā said they feltĀ itsĀ health benefitsĀ than did thoseĀ givenĀ Avonex (interferon beta-1a) ā demonstrating that patient-reported outcomes do mirror objective measures of improved health in a clinical trial ofĀ the two drugs. Patient-reported changesĀ in both physical and psychological health contribute to a more comprehensive picture of…
December 13, 2016 News by Patricia Silva, PhD Zinbryta Approved in Canada as Once-Monthly Treatment for Relapsing MS Health CanadaĀ has approved Zinbryta (daclizumab)Ā as aĀ treatment for adults with active relapsing-remittingĀ multiple sclerosis (RRMS), BiogenĀ and AbbVieĀ announced. Zinbryta is a long-acting injection therapy, self-administered monthly, for patients who have had an inadequate response to at least two other MS therapies. “ZINBRYTAā¢ is the first once-monthly, self-administered treatment…
October 5, 2016 News by Patricia Silva, PhD MS Trust to Oppose NICE Plan to Reject Zinbryta as MS Therapy in Health System for England, Wales The Multiple Sclerosis (MS) Trust isĀ expressing its disappointment at the recent committee decision ofĀ theĀ National Institute for Health and Care ExcellenceĀ (NICE)Ā to not recommendĀ Zinbryta (daclizumab) be made available as a therapy to MSĀ patients using the public health system in England and Wales. NICE’sĀ preliminary recommendationĀ was based on a review of…
October 4, 2016 News by Patricia Silva, PhD NICE Planning to Reject MS Treatment, Zinbryta, in England and Wales TheĀ National Institute for Health and Care Excellence (NICE), the health authorityĀ for England and Wales,Ā has decided not to recommend Zinbryta (daclizumab)Ā be made available to multiple sclerosis (MS)Ā patients through the country’s health service. The decision came in a first stage of the drugās review process, and NICE is welcoming…
September 19, 2016 News by Patricia Silva, PhD #ECTRIMS2016 – Biogen and AbbVie Present New Positive Data on Zinbryta to Treat Relapsing MS BiogenĀ andĀ AbbVieĀ presented positive new post-hoc analysis from the pivotal DECIDE clinical trial, whichĀ showed that a significantly larger number of relapsing multiple sclerosis (RMS) patients treated with Zinbryta (daclizumab) hadĀ no evidence of disease activity (NEDA)Ā compared to thoseĀ treated with Avonex (interferon beta-1a).Ā The data wereĀ given at the recentĀ 32nd Congress of the European…
September 12, 2016 News by Patricia Silva, PhD #ECTRIMS2016 – Biogen to Unveil Study into Economic and Human Costs of MS At theĀ European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2016 Congress, taking placeĀ inĀ London on Sept. 14ā17, Biogen will present the Multiple Sclerosis Cost of Illness study, based on research intoĀ more than 16,000 MS patients throughout Europe. The study builds on data from a leading 2005 study that…
August 17, 2016 News by Patricia Silva, PhD Zinbryta, a Relapsing MS Therapy, Now Available at Diplomat Pharmacy in US Diplomat Pharmacy, theĀ largest independent specialty pharmacy in the U.S., is nowĀ dispensing the limited-distribution drug Zinbryta (daclizumab) as a therapy for relapsing multiple sclerosis (MS). ZinbrytaĀ was recently approved by the U.S. Food and Drug Administration (FDA), and is indicated for the treatment of adult patients with relapsing MS.
July 7, 2016 News by Patricia Inacio, PhD Zinbryta (Daclizumab) Approved in Europe to Treat Relapsing MS Biogen and AbbVieĀ announced that the drug ZinbrytaĀ (daclizumab) has received marketing authorization by the European Commission, and is an approved treatment across most ofĀ Europe forĀ adults with relapsing forms of multiple sclerosis (MS). Zinbryta is a self-administered, once monthly subcutaneous injection. āClinical data showed Zinbryta significantly reduced relapses, 24-week…
June 1, 2016 Columns by admin Side Effects of Zinbryta, an FDA-approved MS Drug, Need to Be Considered Too Editor’s Note: The opinions expressed in this blog post are not the opinions of Multiple Sclerosis News Today. Our MS Blog series offers patient experts to engage in patient-focused topics that are meant to spark discussion and debate in the Multiple Sclerosis community. The opinions of our bloggers are entirely…
May 31, 2016 News by Patricia Silva, PhD Multiple Sclerosis treatment Zinbryta (Daclizumab) Approved by FDA Zinbryta (daclizumab) was approved May 27 for the treatment of adults with relapsing multiple sclerosis (MS). The U.S. Food and Drug Administration (FDA) cleared Biogenās new long-acting injection as a patient self-administered monthly therapy. The director of Neurology Products at the U.S. FDAās Center for Drug Evaluation…
May 4, 2016 News by Patricia Silva, PhD CHMP Favors European Approval of Zinbryta (Daclizumab) to Treat Relapsing MS The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recently recommended marketing authorization to Zinbryta (daclizumab) for the treatment of patients with relapsing multiple sclerosis (RMS). Zinbryta (daclizumabĀ HYP) is a humanized monoclonal antibody that is injected every four weeks, and being developed by…
April 22, 2016 News by Patricia Silva, PhD Biogen and AbbVie Present New Data Showing Zinbryta, an RRMS Drug Candidate, Aids Cognition Without Immune Depletion New data presented byĀ BiogenĀ andĀ AbbVieĀ at the recent 68th annual meeting of theĀ American Academy of Neurology (AAN) showed that ZinbrytaĀ (daclizumab high-yield process) improved cognitive outcome measures in patients with relapsing forms of multiple sclerosis (RMS). Additional results ā from post-hoc analyses of clinicalĀ trials ā also offer a better…
April 14, 2016 News by admin Array of Multiple Sclerosis Trial Data to Be Presented by Biogen at 2016 AAN Meeting A rangeĀ of new multiple sclerosis (MS) data from Biogen will be revealedĀ atĀ the 68th annual meeting of the American Academy of Neurology (AAN) in Vancouver, Canada, on April 15ā21. Presentations will include studies on TecfideraĀ (dimethyl fumarate),Ā one of the most frequently usedĀ oral MS treatments worldwide, as well as several other…
October 2, 2015 News by Patricia Silva, PhD Biogen to Present New Data at Upcoming ECTRIMS 2015 Congress on MS Therapies, Including TECFIDERA Biogen, a biotechnology company focused on innovative therapies for autoimmune disorders, neurodegenerative diseases and hematological conditions, recently announced that it will present new data on its multiple sclerosis (MS) portfolio of therapeutic agents at the upcoming 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis…
May 6, 2015 News by Patricia Silva, PhD FDA Evaluates ZINBRYTA For MS Treatment The U.S. Food and Drug Administration (FDA) has announced it willĀ considerĀ marketing approval ofĀ ZINBRYTA (daclizumab high-yield process), a potential treatment for relapsing forms of multiple sclerosis (MS). Biogen and AbbVie, who are jointly developing the therapy, have filed aĀ Biologics License Application…
September 22, 2014 News by Maureen Newman New MS Therapy From Biogen Idec, AbbVie Reveals Positive Phase 3 Results in RRMS Patients Phase 3 clinical trial results from Biogen Idec and AbbVie presented at the Sixth Triennial Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS-ECTRMIS) suggest that relapsing-remitting multiple sclerosis patients experience…