Manufacturers of the MS drug daclizumab, which is sold under the brand name Zinbryta, have announced that they will be voluntarily removing the drug from sale. The news follows recent calls from the European Medicines Agency for an “urgent review” of the drug after eight reported cases of serious brain inflammation across parts of Europe. All the cases of brain inflammation were reported in Europe, with seven being in Germany and the other being in Spain.
The companies said in a statement that: “Given the nature and complexity of adverse events being reported, characterizing the evolving benefit/risk profile of Zinbryta will not be possible going forward given the limited number of patients being treated. Therefore, Biogen and AbbVie believe it is in the best interest of patients to voluntarily withdraw worldwide marketing authorizations for Zinbryta.”
According to the National Multiple Sclerosis Society, the disease affects over 2.3 million people across the world. The drug daclizumab is an immune-modulating therapy which is available in Europe, the US, Canada and Australia and it’s estimated that over 8000 patients currently use the drug. Although the therapy has been approved for use in the US, the FDA has previously warned that it could pose dangerous side effects. The agency noted in a statement in 2016 that the drug could cause “serious or life-threatening liver damage” and “serious immune system disorders (conditions that occur when the immune system attacks healthy cells in the body).”
Due to some of the concerns raised, the drug was only available via restricted distribution programmes by a doctor who’s registered to prescribe the drug. The programme also includes regular monitoring, and ensures that the drug is not given to those with liver disease, those taking other medication for MS or those with skin problems like psoriasis. In addition to this, patients who were being prescribed the medication were required to try at least other treatments before trying daclizumab.
In light of the withdrawal of the drug from the market, the European Medicines Agency said that it will be contacting doctors to provide further advice. It has also urged that doctors should be contacting existing patients who are taking daclizumab, and check for any signs of brain inflammation. It’s been advised that new patients shouldn’t be offered the drug until investigation have taken place. However, they’ve noted that patients already taking the drug shouldn’t stop taking it unless advised to do so by a doctor.