On May 27, the U.S. Food and Drug Administration (FDA) announced the approval of Zinbryta (daclizumab) for relapsing multiple sclerosis. Zinbryta is a monthly, long-acting, self-administered injection.
Due to safety risk, the FDA cautions the therapy should only be used after two or more previous treatments have failure of response. Safety risks include severe liver injury, which could potentially be fatal. Liver function should be tested prior to administration and before each monthly dose. Patient’s liver function should also be tested for 6 months after ending the treatment. Other high risks include “immune conditions, such as inflammation of the colon (non-infectious colitis), skin reactions, and enlargement of lymph nodes (lymphadenopathy).” 1
Zinbryta has a boxed warning and is only available through the Risk Evaluation and Mitigation Strategy program.
In one clinical trial, in comparison with Avonex, 1,841 participants over 144 weeks experienced fewer relapses on Zinbryta. In a second clinical trial, 412 participants over 52 weeks were treated with Zinbryta or a placebo. Participants receiving Zinbryta experienced fewer relapses than those on the placebo.
In the comparison with Avonex, participants on Zinbryta reported more “cold symptoms (nasopharyngitis), upper respiratory tract infection, rash, influenza, dermatitis, throat (oropharyngeal) pain, eczema, and enlargement of lymph nodes.” In comparison with the placebo, participants on Zinbryta reported more “depression, rash, and increased alanine aminotransferase.” 1
Zinbryta is marketed by Biogen, Inc.1-2
For more information regarding Zinbryta’s FDA approval, visit the press release.