Drug for Relapsing Forms of Multiple Sclerosis Pulled from Market
Biogen and AbbVie recently announced a voluntary, worldwide withdrawal of daclizumab (ZinbrytaÂ®).
Biogen and AbbVie recently announced a voluntary, worldwide withdrawal of daclizumab (Zinbryta). Zinbryta was approved by the FDA on May 27, 2016 for treatment of adults with relapsing forms of multiple sclerosis, and is available as a once-a-month, subcutaneous injection.
The withdrawal, announced March 2, is a result of the European Medicines Agency initiating an Article 20 referral procedure after reports of inflammatory encephalitis and meningoencephalitis. Because there are so few patients with multiple sclerosis who receive this medication, characterization of the risk/benefit profile is not possible, according to the drug manufacturer.
According to Alfred Sandrock, MD, PhD, and executive vice president and chief medical officer at Biogen, "Biogen believes the voluntary worldwide withdrawal of ZINBRYTA, a treatment for relapsing multiple sclerosis, is in the best interest of patients."
Zinbryta has been on the market in the EU, the US, Switzerland, Canada, and Australia, and was generally reserved for patients with relapsing forms of multiple sclerosis who have tried and failed 2 or more medications. Biogen encourages patients currently treated with Zinbryta to contact their health care providers if they have questions or concerns, and officials said they will work collaboratively with authorities and healthcare providers in the management of Zinbryta patients.
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- Lexicomp [Internet]. Hudson, Ohio: Wolters Kluwer. c1978-2018. Daclizumab; [updated 2018 March 02; cited 2018 March 08]; Available from:https://online.lexi.com/lco/action/doc/retrieve/docid/patch_f/6686
- Biogen and AbbVie Announce the Voluntary Worldwide Withdrawl of Marketing Authorizations for ZINBRYTA® (daclizumab) for Relapsing Multiple Sclerosis. [news release]. Cambridge, MA and North Chicago, IL. Biogen and AbbVie. March 2, 2018. http://newsroom.biogen.com/press-release/autoimmune-diseases/biogen%C2%A0and-abbvie-announce%C2%A0-voluntary%C2%A0worldwide-withdrawal-marketi. Accessed 8 Mar. 2018.