ZINBRYTA

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)ā€™s Pharmacovigilance Risk Assessment Committee (PRAC). Zinbryta was authorized…

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BiogenĀ and AbbVieĀ have voluntarily withdrawn global marketing authorizations for theirĀ relapsing multiple sclerosisĀ therapyĀ Zinbryta (daclizumab) because of serious side effects that include brain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…

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

  The United Kingdomā€™sĀ 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…

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…

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…

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…

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 drugā€™s review process, and NICE is welcoming…

#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…

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. ā€œClinical data showed Zinbryta significantly reduced relapses, 24-week…

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…

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 15ā€“21. Presentations will include studies on TecfideraĀ (dimethyl fumarate),Ā one of the most frequently usedĀ oral MS treatments worldwide, as well as several other…

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…

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…