EMA concludes review of Zinbryta and confirms further restrictions to reduce risk of liver damage
Press release
Human
The European Medicines Agency (EMA) has concluded its review of the multiple sclerosis medicine Zinbryta (daclizumab) and confirmed further restrictions to reduce the risk of serious liver damage.
The review found that unpredictable and potentially fatal immune-mediated liver injury can occur during treatment with Zinbryta and for up to 6 months after stopping treatment. In clinical trials, 1.7% of patients receiving Zinbryta had a serious liver reaction.
Zinbryta should now only be used in patients who have had an inadequate response to at least two disease modifying therapies (DMTs) and cannot be treated with any other DMTs. Details of the recommendations for patients and healthcare professionals are given below.
The review of the liver effects of Zinbryta was conducted by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which issued recommendations in October 2017.
The Committee for Medicinal Products for Human Use (CHMP) has now adopted EMA's final opinion, which will be sent to the European Commission for adoption of a legally binding decision.
Information for patients
Information for healthcare professionals
More about the medicine
Zinbryta is a medicine used to treat certain patients with relapsing forms of multiple sclerosis. Multiple sclerosis is a disease in which inflammation damages the protective sheath around the nerve cells in the brain and spinal cord. Relapsing means that the patient has flare-ups of neurological symptoms.
Zinbryta is available as a solution for injection in pre-filled pens and syringes. It is injected under the skin once a month.
Zinbryta contains the active substance daclizumab and was authorised in the EU in July 2016. More information can be found on the medicine's dedicated page on EMA's website.
More about the procedure
The review of Zinbryta was initiated on 9 June 2017 at the request of the European Commission under Article 20 of Regulation (EC) No 726/2004.
The review has been carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations. The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's opinion.
The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.