BIOGEN — Zinbryta FDA Summary Review (NDA/BLA 761029, 2016)
BIOGEN · 2016 · FDA Summary Review (Drugs@FDA) · company profile →
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The FDA review of daclizumab (Zinbryta) for relapsing multiple sclerosis recommends approval despite significant safety concerns. Efficacious in reducing annualized relapse rates compared to placebo and Avonex, its use is advised for patients unresponsive to other therapies. However, severe risks include hepatic injury, immune-mediated disorders (e.g., sarcoidosis, glomerulonephritis), depression, seizures, and potential breast cancer. A boxed warning and a robust Risk Evaluation and Mitigation Strategy (REMS) with elements to assure safe use, including a patient registry, are mandated to mitigate these serious adverse events. First-line use is restricted due to the drug's safety profile.
Key findings — cited to the page
| Vasculitis incidence in DAC-treated subjects | 0.3 % | · p.16 |
| Celiac disease incidence in DAC-treated subjects | 0.2 % | · p.16 |
| Deaths in DAC-treated patients | 5 | · p.15 |
| Deaths in Avonex-treated patients | 5 | · p.15 |
| Sarcoidosis incidence in DAC-treated subjects | 0.3 % | · p.16 |
| Serious DILI incidence in DAC subjects | 0.9 % | · p.15 |
| Autoimmune hepatitis incidence in DAC subjects | 7 | · p.15 |
| Immune-mediated adverse events incidence in DAC-treated subjects | 30 % | · p.16 |
| Psoriatic conditions incidence in DAC-treated subjects | 2 % | · p.16 |
| Enteropathy incidence in DAC-treated subjects | 1.2 % | · p.16 |
| Immune-mediated hepatitis incidence in DAC-treated subjects | 0.53 % | · p.16 |
| Glomerulonephritis incidence in DAC-treated subjects | <0.1 % | · p.16 |
Source: BIOGEN ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Immunology library →