Zinbryta Voluntarily Withdrawn from Market
March 2, 2018 – AbbVie and Biogen have voluntarily withdrawn Zinbryta® (daclizumab), a multiple sclerosis (MS) treatment, from the global market. The action follows reports of inflammatory encephalitis and meningoencephalitis—both diseases that cause swelling of the brain—in patients who took the drug.
In a joint press release from the two companies, Dr. Alfred Sandrock, Executive Vice President and Chief Medical Officer at Biogen, stated that the withdrawal was “in the best interest of patients.” The press release further stated that both companies believe it impossible at this time to further examine the risk/benefit profile of Zinbryta due to a limited number of patients who have taken the drug.
Zinbryta was first approved for use in the U.S. in 2016. Prior to its withdrawal from market, the product was also available in the EU, Switzerland, Canada, and Australia. Zinbryta had already carried a black box warning for risk of liver failure. As a result, it was considered a treatment only for patients who had tried at least two other MS drug therapies without obtaining sufficient benefit.
Patients currently on Zinbryta are asked to speak to their healthcare provider about their options. AbbVie and Biogen have announced they will support officials and healthcare professionals in the removal of Zinbryta from the market, and in the management of patients who have used the medication.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.