BRUSSELS, Nov. 10 (Xinhua) -- The European Medicines Agency (EMA) on Friday confirmed further restrictions on the medicine Zinbryta to reduce the risk of serious liver damage.
EMA said in a press release that this medicine will be used in a restricted patient group, with strict liver monitoring.
Zinbryta is a medicine used to treat certain patients with relapsing forms of multiple sclerosis. It contains the active substance daclizumab and was authorized in the European Union in July 2016.
EMA's Pharmacovigilance Risk Assessment Committee (PRAC) in the end of October recommended further restrictions and the Committee for Medicinal Products for Human Use (CHMP) has adopted EMA's final opinion.
The opinion will now be sent to the European Commission for adoption of a legally binding decision.
According to the release, PRAC recommended that doctors should only prescribe Zinbryta for relapsing forms of multiple sclerosis in patients who have had an inadequate response to at least two disease modifying therapies (DMTs) and cannot be treated with other DMTs in order to reduce risks.
At the same time, doctors should also monitor patients' liver function at least once a month as closely as possible before each treatment and continue monitoring them for up to six months after treatments have stopped, it suggested.
