PRAC July meeting highlights include restrictions on Zinbryta

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC),at its meetings over July 3-6, said it is provisionally restricting the use of the multiple sclerosis medicine Zinbryta (daclizumab) to patients with highly active relapsing disease that failed to respond to certain other treatments, and to patients with rapidly evolving relapsing disease who cannot be treated with other medicines.

In July 2016, the European Commission (EC) has granted marketing authorization for US firms Biogen (Nasdaq: BIIB) and AbbVie’s (NYSE: ABBV) Zinbryta to treat adults with relapsing forms of multiple sclerosis (RMS).

The PRAC now says that patients with liver injury must not be given the medicine. Doctors should continue to monitor the liver function of patients receiving the medicine and closely monitor patients for signs and symptoms of liver injury. This recommendation is an interim measure taken to protect public health while the review of Zinbryta is still ongoing.