Drug companies, AbbVie and Biogen have initiated a voluntary global withdrawal of the relapsing MS medication Zinbryta (daclizumab).
This follows several reports of brain inflammation (encephalitis) or inflammation of the membranes surrounding the brain (meningoencephalitis) in a small number of people being treated with Zinbryta.
Clinical trials showed that Zinbryta was able to significantly reduce the risk of relapses, reduce lesions in the brain and delay disability progression. Adverse events (side-effects) noted in the clinical trials included a slightly increased risk of infections, anaemia, depression, rash, fever and liver changes. 2% of people in the trials experienced serious adverse events which were predominantly infections. As a result of these clinical trials, Zinbryta was authorised for use in Europe, USA, Canada, Switzerland and Australia.
It is a requirement following the introduction of any new medication, that there is ongoing monitoring and tracking of the side-effects and benefits of the drug. This is known as post-marketing surveillance. From time to time this process identifies new risks and side-effects that did not show up during the timeframe of the clinical trials.
In the case of Zinbryta, the newly identified adverse events that have emerged suggest that the potential risks of the medication may outweigh its potential benefits for patients.
Biogen, the company that markets the drug in Australia, have advised that they are working with the Australian Therapeutic Goods Administration to plan and coordinate the withdrawal of the drug. We will bring you any further information as we have it.
In the meantime, people who are currently being treated with Zinbryta should not stop taking their medication, but should seek advice from their neurologist about alternative treatment options and ongoing safety monitoring.