Zinbryta is a monoclonal antibody co-developed by AbbVie and Biogen and was first approved in Europe to treat adults with relapsing forms of multiple sclerosis in July 2016, a month after receiving approval in the US.
However, safety concerns led to an EMA review last year, which 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. Restrictions were placed on it use last year.
But now the EMA has recommended the immediate suspension of Zinbryta’s marketing authorisation in the EU and has recalled batches from pharmacies and hospitals following 12 reports of serious inflammatory brain disorders worldwide, three of which were fatal.
“No new patients should start treatment with Zinbryta. Healthcare professionals should immediately contact patients currently being treated with Zinbryta and should stop their treatment and consider alternatives. Patients stopping treatment must be followed up for at least 6 months.”
The recommendation – set to be legally binding by the European Commission – comes a few days after Biogen and AbbVie announced a voluntary worldwide recall of the drug, “in the best interest of patients.”
Biogen added it will “continue to work collaboratively with regulatory authorities in the withdrawal of product and with healthcare providers worldwide in their support of Zinbryta patients.”