Escalating concerns about the safety of Zinbryta (daclizumab) - and particularly cases of liver damage and immune-related conditions - are behind the decision, which was announced on the same day that the EMA started an ‘urgent review’ of Zinbryta.
In a statement, Biogen said that given the “nature and complexity of adverse events being reported”, as well as the “limited number of patients being treated” with the drug, it was better to withdraw it from the market altogether.
Last November the EMA reported that it had safety concerns about the product that caused it to restrict prescribing to patients who have tried at least two other disease-modifying treatments and cannot be treated with any other MS treatments.
The drug had been launched to date in the EU, US, Switzerland, Canada and Australia and developed a modest following because it is dosed just once a month by self-administered injection, less frequently than interferon beta therapies.
The EMA recommends that doctors should review patients currently treated with Zinbryta “and initiate alternative therapy, as soon as possible”.