Zinbryta (daclizumab), a Therapy for Relapsing MS, is Withdrawn from Market - UPDATED with FDA Info
March 15, 2018
UPDATE -- Originally posted 3/2/18
- Biogen and AbbVie have announced the voluntary withdrawal Zinbryta ™ (daclizumab) from the worldwide market.
- Zinbryta is an immune-modulating therapy that was approved in 2016 for people with relapsing MS and generally reserved for people who had an inadequate response to two or more MS therapies.
- According to a company press release, the European Medicines Agency had raised new safety concerns related to reports of inflammation of the brain or its surrounding tissues (inflammatory encephalitis and meningoencephalitis) among people taking Zinbryta.
- The FDA is working closely with manufacturers to ensure an organized withdrawal, according to a March 14 update on the FDA website.
- Individuals currently taking Zinbryta should not stop their medication without talking with their healthcare provider, and should contact their doctor immediately if they have any new and unexplained symptoms. Their healthcare providers can help them to determine alternative treatment options, and take steps to continue safety monitoring. According to the medication guide, this would include monthly blood tests to monitor liver function for up to six months after the last dose.
- Zinbryta will be available as needed until April 30, 2018.
- Any questions or concerns about the withdrawal can be directed to the manufacturers’ service center at 1-800-456-2255 or the manufacturer’s website at www.zinbryta.com.
Multiple sclerosis is an unpredictable disease of the central nervous system. Currently there is no cure. Symptoms vary from person to person and may include disabling fatigue, mobility challenges, cognitive changes, and vision issues. An estimated 1 million people live with MS in the United States. Early diagnosis and treatment are critical to minimize disability. Significant progress is being made to achieve a world free of MS.