Zinbryta (daclizumab), a Therapy for Relapsing MS, is Withdrawn from Market - UPDATED with FDA Info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.
About Multiple Sclerosis
Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system. Symptoms range from numbness and tingling to blindness and paralysis, and there is currently no cure for MS. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. An estimated 1 million people live with MS in the United States. Most people with MS are diagnosed
between the ages of 20 and 50, and it affects women three times more than men.
About the National Multiple Sclerosis Society
The National MS Society, founded in 1946, funds cutting-edge research, drives change through advocacy, and provides programs and services to help people affected by MS live their best lives. Connect to learn more and get involved: nationalMSsociety.org, Facebook, Twitter, Instagram, YouTube or 800-344-4867.