daclizumab (zinbryta0) and multiple sclerosis after multiple treatment failures A drug that should never have been authorised

摘要

Evaluation of daclizumab in multiple sclerosis is mainly based on two double-blind randomised clinical trials including about 2500 patients with a relapsing-remitting form of the disease, most of whom had not previously received "disease-modifying" therapy. Daclizumab was slightly more effective than interferon beta-la and placebo in reducing the frequency of relapses, but its efficacy after multiple treatment failures remains unknown. Daclizumab can provoke severe and sometimes fatal adverse effects, in particular liver injury, infections, gastrointestinal disorders, skin disorders and depression. In light of daclizumab's unfavourable harm-benefit balance, it is regrettable that the European Medicines Agency (EMA) authorised this drug. In March 2018, after several deaths had occurred, its European marketing authorisation was withdrawn.