Pharmaceutical companies AbbVie and Biogen have voluntarily begun the process of removing the drug Zinbryta (daclizumab) from the market worldwide. The drug was intended to treat patients with multiple sclerosis (MS) after other drugs failed to work. It was approved in the U.S. by the Food and Drug Administration (FDA) in 2016 and that agency is now working with the companies to get it off the market after several reports of inflammatory brain diseases.
Zinbryta for Multiple Sclerosis
MS is a chronic, often progressive or recurring illness that causes the immune system to attack the central nervous system. The level of disability it causes varies by individual, but the symptoms can lead to a significant degree of loss of function. Many people living with MS experience episodes of worse symptoms, followed by periods of remission.
The FDA approved Zinbryta as a treatment for MS in 2016 after the results of two clinical trials with over 2,000 participants showed that it could reduce relapses of symptom episodes. The approval came with the recommendation that the drug only be used after a patient gets no results with two or more other MS drugs because of the potential for serious side effects. These include damage to the liver and immune system conditions. The risks are serious enough that the FDA made Zinbryta available only through a program with restricted distribution.
Brain Inflammation and Recall
In March, 2018, the European Medicines Agency (EMA), which regulates drugs in Europe as the FDA does in the U.S. released a statement that it would be reviewing Zinbryta and recommending it be recalled immediately. This came after 12 reports of serious brain inflammation in multiple countries. This included cases of meningoencephalitis and encephalitis. Three of the patients who developed inflammatory brain diseases died.
Immediately following the announcement by the EMA, Biogen and AbbVie announced they would be voluntarily suspending Zinbryta, making the drug available through the end of April only. They also announced the closing of all clinical trials involving the drug.
The FDA also announced that it would work closely with the drug companies to make sure the withdrawal of the product from the market goes smoothly. The agency is also helping physicians to transition their patients off Zinbryta and on to alternative medications. The FDA as well as the EMA is reviewing the events, although it is currently assumed that the brain inflammation cases were triggered by the medication.
Patients who were using or are using Zinbryta should contact their prescribing doctors immediately to find out what to do next. Both the FDA and EMA recommend that patients not take another dose of the drug until talking to their physicians. The symptoms patients should be watching for and reporting immediately include a fever, severe headache, fatigue, nausea, and yellowing in the skin and eyes. Doctors should also test patients for several months after stopping use of Zinbryta to check for inflammation and liver damage, and to address any issues as soon as possible.