Daclizumab approved for relapsing forms of multiple sclerosis
On May 27, 2016 the FDA announced the approval of Zinbryta(daclizumab) by Biogen for the treatment of adults with relapsing forms of MS. Daclizumab is the first subcutaneous injectable monoclonal antibody to be approved for the treatment of MS. However, due to its safety profile daclizumab should be reserved for patients with inadequate response to two or more MS medications. Daclizumab is an interleukin-2 antagonist monoclonal antibody, increasing the level of natural killer cells which appears to be a biomarker for reductions in brain inflammatory activity in MS patients.
The effectiveness of daclizumab was shown in two randomized, double-blind trials in patients with relapsing-remitting MS. In the SELECT trial patients between 18-55 years of age with relapsing-remitting MS were randomly assigned (1:1:1) to subcutaneous injections of daclizumab 150mg, daclizumab 300mg or placebo administered every 4 weeks for 52 weeks. One hundred eighty-eight patients were randomized to placebo, 192 to daclizumab 150mg, and 209 to daclizumab 300mg and completed follow up at week 52. The relapse rate was lower for daclizumab 150mg (0.21, 95% CI 0.16–0.29 p<0.0001) and 300 mg (0.23, 0.17–0.31, p=0.00015) than for placebo (0.46, 0.37–0.57). The percentage of patients with confirmed disability progression at week 52 was 6% with daclizumab and 13% with placebo. It was determined that daclizumab 150mg was the most appropriate dose based on the similar efficacy outcomes and fewer serious adverse events, 15(7%) for daclizumab 150mg and 19 (9%) for daclizumab 300mg.