Editor’s 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. Symptoms of MS Uhthoff’s phenomenon People with MS are often heat-sensitive and experience overheating due to…
Daclizumab
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 of encephalitis or meningoencephalitis have been reported in patients using Zinbryta, and…
Biogen and AbbVie have voluntarily withdrawn global marketing authorizations for their relapsing multiple sclerosis therapy Zinbryta (daclizumab) because of serious side effects that include brain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…
Zinbryta (daclizumab) may not be the best follow-up therapy for relapsing–remitting 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 “Disease reactivation after switching from natalizumab to daclizumab,” was published in…
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…
The United Kingdom’s National Institute for Health and Care Excellence (NICE) last month recommended Zinbryta (daclizumab) to treat relapsing-remitting multiple sclerosis (RRMS) in England and Wales. On April 10, Scotland received Scottish Medicines Consortium (SMC) approval for the National Health Service (NHS) to prescribe Zinbryta as a treatment for RRMS. Zinbryta is…
The United Kingdom’s National Institute for Health and Care Excellence (NICE) has cleared its initial doubts and now recommends Zinbryta (daclizumab) to treat relapsing multiple sclerosis (MS) in England and Wales. NICE had initially rejected Zinbryta after a first stage of the drug’s review process, due to some issues linked to…
News that daclizumab, brand name Zinbryta, has been given the go-ahead to be available through the U.K.’s National Health Service (NHS) for treating relapsing MS, at least in part of the country, is good news. But why has the decision taken…
More relapsing multiple sclerosis (MS) patients treated with Zinbryta (daclizumab) said they felt its health benefits than did those given Avonex (interferon beta-1a) — demonstrating that patient-reported outcomes do mirror objective measures of improved health in a clinical trial of the two drugs. Patient-reported changes in both physical and psychological health contribute to a more comprehensive picture of…
News
MS Trust to Oppose NICE Plan to Reject Zinbryta as MS Therapy in Health System for England, Wales
The Multiple Sclerosis (MS) Trust is expressing its disappointment at the recent committee decision of the National Institute for Health and Care Excellence (NICE) to not recommend Zinbryta (daclizumab) be made available as a therapy to MS patients using the public health system in England and Wales. NICE’s preliminary recommendation was based on a review of…
The National Institute for Health and Care Excellence (NICE), the health authority for England and Wales, has decided not to recommend Zinbryta (daclizumab) be made available to multiple sclerosis (MS) patients through the country’s health service. The decision came in a first stage of the drug’s review process, and NICE is welcoming…
Biogen and AbbVie presented positive new post-hoc analysis from the pivotal DECIDE clinical trial, which showed that a significantly larger number of relapsing multiple sclerosis (RMS) patients treated with Zinbryta (daclizumab) had no evidence of disease activity (NEDA) compared to those treated with Avonex (interferon beta-1a). The data were given at the recent 32nd Congress of the European…
Diplomat Pharmacy, the largest independent specialty pharmacy in the U.S., is now dispensing the limited-distribution drug Zinbryta (daclizumab) as a therapy for relapsing multiple sclerosis (MS). Zinbryta was recently approved by the U.S. Food and Drug Administration (FDA), and is indicated for the treatment of adult patients with relapsing MS.
Biogen and AbbVie announced that the drug Zinbryta (daclizumab) has received marketing authorization by the European Commission, and is an approved treatment across most of Europe for adults with relapsing forms of multiple sclerosis (MS). Zinbryta is a self-administered, once monthly subcutaneous injection. “Clinical data showed Zinbryta significantly reduced relapses, 24-week…
The Institute of Clinical and Economic Review (ICER) released the early draft of a paper intended to inform a future report evaluating the effectiveness and value of disease-modifying therapies for relapsing-remitting multiple sclerosis (RRMS). The paper, called a draft scoping document, is titled “Disease Modifying Therapies for Relapsing-Remitting Multiple Sclerosis: Effectiveness and…
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 Biogen’s new long-acting injection as a patient self-administered monthly therapy. The director of Neurology Products at the U.S. FDA’s Center for Drug Evaluation…
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 (daclizumab HYP) is a humanized monoclonal antibody that is injected every four weeks, and being developed by…
New data presented by Biogen and AbbVie at the recent 68th annual meeting of the American Academy of Neurology (AAN) showed that Zinbryta (daclizumab high-yield process) improved cognitive outcome measures in patients with relapsing forms of multiple sclerosis (RMS). Additional results — from post-hoc analyses of clinical trials — also offer a better…
A range of new multiple sclerosis (MS) data from Biogen will be revealed at the 68th annual meeting of the American Academy of Neurology (AAN) in Vancouver, Canada, on April 15–21. Presentations will include studies on Tecfidera (dimethyl fumarate), one of the most frequently used oral MS treatments worldwide, as well as several other…
Biogen Idec, who recently presented over 60 company-sponsored presentations at the Consortium of Multiple Sclerosis Centers and the Sixth Cooperative Meeting with Americas Committee for Treatment and…