Zinbryta
Immunology· 61 cited findings· 1 source document
Company: BIOGEN →
What the regulatory reviews say
Zinbryta (daclizumab) is a drug reviewed under NDA/BLA 761029. It demonstrated efficacy in reducing annualized relapse rates. In clinical trials, Zinbryta reduced annualized relapse rates by 54% compared to placebo and by 45% compared to an active control. These efficacy findings were observed over study durations of 1 to 2 years.
Safety concerns included a 0.9% incidence of serious drug-induced liver injury (DILI) and a 0.53% incidence of immune-mediated hepatitis in DAC-treated subjects. Other immune-mediated adverse events occurred in 30% of DAC-treated subjects, including psoriatic conditions (2%), enteropathy (1.2%), sarcoidosis (0.3%), and vasculitis (0.3%). Five deaths were reported in DAC-treated patients, matching the number in Avonex-treated patients.
The FDA recommended a Risk Evaluation and Mitigation Strategy (REMS) for Zinbryta, which was deemed necessary and required. This REMS included a communication plan, certified prescribers and pharmacies, documentation of safe-use conditions, specified monitoring, and a patient registry. Strong warnings, including a boxed warning for DILI and immune-mediated events, were recommended. The drug was not recommended for first-line use, and a pediatric study requirement was waived.
Key figures — cited to the source page
| Annualized relapse rate reduction vs placebo | 54 | BIOGEN — Zinbryta FDA Summary Review (NDA/BLA 761029, 2016), p.12 |
| Annualized relapse rate reduction vs active control | 45 | BIOGEN — Zinbryta FDA Summary Review (NDA/BLA 761029, 2016), p.12 |
| Serious DILI incidence in DAC subjects | 0.9 | BIOGEN — Zinbryta FDA Summary Review (NDA/BLA 761029, 2016), p.15 |
| Immune-mediated adverse events incidence in DAC-treated subjects | 30 | BIOGEN — Zinbryta FDA Summary Review (NDA/BLA 761029, 2016), p.16 |
| Deaths in DAC-treated patients | 5 | BIOGEN — Zinbryta FDA Summary Review (NDA/BLA 761029, 2016), p.15 |
| REMS recommendation | required | BIOGEN — Zinbryta FDA Summary Review (NDA/BLA 761029, 2016), p.17 |
| Recommended warnings | strong warnings, boxed warning for DILI and immune-mediated events | BIOGEN — Zinbryta FDA Summary Review (NDA/BLA 761029, 2016), p.18 |
| Recommended use restriction | not for first line use | BIOGEN — Zinbryta FDA Summary Review (NDA/BLA 761029, 2016), p.18 |
Source documents
Explore the full evidence
All 61 cited findings for Zinbryta — searchable, comparable and answerable in plain language — are in the Immunology research library →
Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.