What’s the Problem?
Zinbryta, a multiple sclerosis medication developed in a joint partnership between AbbVie and BioGen, was withdrawn from the global market in March 2018 amid reports of severe brain inflammation and deaths in patients treated with the drug.
What is Zinbryta?
Zinbryta is a disease-modifying therapy for adults with relapsing forms of multiple sclerosis. The drug is classified as an immune-modulating therapy which is taken by under-the-skin injection every 4 weeks.
Zinbryta Side Effects
Our lawyers are filing lawsuits on behalf of people who suffered the following serious side effects while taking Zinbryta:
- Liver failure
- Drug-induced hepatitis
- Inflammatory encephalitis
Black Box Warning
FDA said it has been aware of the “complex safety profile of Zinbryta” since it was first approved in March 2016. Since then, the serious side effects associated with the drug have led to a “black-box warning” — the strictest warning the FDA can require on a prescription drug or medical device — about the risk of serious liver injury and other immune-mediated disorders, along with a recommendation to only prescribe the medicine to patients who haven’t responded well to 2 or more multiple sclerosis drugs.
Was There a Warning About Encephalitis?
The severity of Zinbryta side effects have led to a Risk Evaluation and Mitigation Strategy (REMS) which makes the drug only available through a restricted distribution program. Neither Biogen nor Abbvie warned consumers or physicians about the risk of encephalitis or Stevens Johnson Syndrome (SJS) from Zinbryta.
Encephalitis is an inflammation of the brain, caused by infection or an allergic reaction, according to the Mayo Clinic. The condition often causes only mild, flu-like symptoms — such as a fever or headache — or no symptoms at all. However, in some cases, symptoms are more severe and include confused thinking, seizures, or problems with senses or movement.
Mar 2007 – Primary Endpoint Met
Mar 12, 2007 – Primary Endpoint Met in Phase 2 Trial of Daclizumab in Patients With Relapsing Multiple Sclerosis.
Oct 2007 – Data Shows Multiple Sclerosis Lesions Reduced
Oct 12, 2007 – Phase 2 Data Show Daclizumab Significantly Reduced Multiple Sclerosis Lesions in Patients Receiving Interferon Beta Therapy.
Feb 2010 – Daclizumab Shows Potential For New Treatment Approach
Feb 16, 2010 – Daclizumab Shows Potential For New Immunoregulatory Approach To Treating Multiple Sclerosis, According To Data Published In The Lancet Neurology.
Aug 2011 – Trial Results Announced
Aug 9, 2011 – Biogen Idec and Abbott Announce Positive Top-Line Results from the First Registrational Trial for Daclizumab HYP in Relapsing-Remitting Multiple Sclerosis.
Apr 2015 – FDA Accepts BLA
Apr 29, 2015 – FDA Accepts BLA for Zinbryta (Daclizumab High-Yield Process) for Treatment of MS. FDA Accepts BLA for Zinbryta (Daclizumab High-Yield Process) for Treatment of MS.
May 2016 – FDA approves Zinbryta
May 27, 2016 – FDA approves Zinbryta for the treatment of of adults with relapsing forms of multiple sclerosis.
March 2018 – Withdrawal plans announced
March 2, 2018 – Biogen and AbbVie announce plans to withdraw Zinbryta globally following reports of inflammatory encephalitis and meningoencephalitis associated with the drug.
- “FDA approves Zinbryta to treat multiple sclerosis”. U.S. Food & Drug Administration (FDA). May 27, 2016.
- “Approved Risk Evaluation and Mitigation Strategies (REMS)”. U.S. Food & Drug Administration (FDA). November 1, 2017.
- Zinbryta Prescribing Information. Biogen. 2016-2017.
- “Biogen and AbbVie Announce the Voluntary Worldwide Withdrawal of Marketing Authorizations for ZINBRYTA® (daclizumab) for Relapsing Multiple Sclerosis”. Biogen. March 2, 2018.
- “Subject: Voluntary withdrawal of ZINBRYTA® (daclizumab) in United States”. Biogen. March 12, 2018.
- “Zinbryta Withdrawal Patient Letter”. March 18, 2018.