PRAC starts new Zinbryta referral; concludes review of docetaxel
At its June meeting, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) started a review of US companies Biogen (Nasdaq: BIIB) and AbbVie’s (NYSE ABBV) Zinbryta (daclizumab) used to treat adults with relapsing forms of multiple sclerosis.
The review follows the death from fulminant liver failure of a patient who was treated with Zinbryta in an ongoing observational study, as well as four cases of serious liver injury.
The PRAC will now evaluate all available data and determine whether there are any implications for the use of the product and if there is a need to introduce any new measures to minimise the risk of liver damage.
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