EMA recommends further restrictions for medicine Zinbryta

European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) recommended on Friday that further restrictions need to be posed on the use of the multiple sclerosis medicine Zinbryta.

EMA said in a press release that this recommendation was made following a review of the medicine's effects on liver.

The review was carried out by PRAC, the Committee responsible for the evaluation of safety issues for human medicines.

It found that unpredictable and potentially fatal immune-mediated liver injury can occur during treatment with Zinbryta and for up to six months after stopping treatment, said 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.

According to EMA, these recommendations will be sent to EMA's Committee for Medicinal Products for Human Use (CHMP), which will adopt the Agency's final opinion.

The review will finally be sent to the European Commission. Once the Commission adopts it, it will be legally applicable in all European Union (EU) member states.

Zinbryta is a medicine used to treat certain patients with relapsing forms of multiple sclerosis. Zinbryta contains the active substance daclizumab and was authorized in the EU in July 2016.