Biogen and AbbVie Voluntarily Withdraw Marketing Authorizations for MS Therapy Zinbryta

Biogen and AbbVie have voluntarily withdrawn global marketing authorizations for their relapsing multiple sclerosis therapy Zinbryta (daclizumab) because of serious side effects that include brain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…

Scottish Medicines Consortium Approves Zinbryta for NHS Treatment of RRMS Patients in Scotland

  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…

Patient Opinions on Zinbryta Seen to Match Phase 3 Trial Data, Supporting Questionnaire Use

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…

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…

#ECTRIMS2016 – Biogen and AbbVie Present New Positive Data on Zinbryta to Treat Relapsing MS

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…

Zinbryta (Daclizumab) Approved in Europe to Treat 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…

ICER Draft Report Evaluating Therapies for RRMS Now Open for Public Comment

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…

Biogen and AbbVie Present New Data Showing Zinbryta, an RRMS Drug Candidate, Aids Cognition Without Immune Depletion

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…