On March 02, 2018, pharmaceutical companies Biogen and AbbVie announced that they are voluntarily withdrawing Daclizumab (Zinbryta) for relapsing multiple sclerosis (MS) off the global markets amidst rising concerns about its safety, including reports of severe liver damage and immunity-related conditions including inflammatory encephalitis and meningoencephalitis34. The companies have also informed EMA of their decision to stop ongoing clinical studies with Zinbryta in the EU.
The announcement from the company came on the same day when the European Medicines Agency announced an "urgent review" of daclizumab after seven cases of serious inflammatory brain disorders occurring in Germany, including encephalitis and meningoencephalitis, and one case in Spain35.
In the European Union, the review of daclizumab was initiated following a request from the European Commission on February 26, 2018, under Article 20 of Regulation (EC) No 726/2004. The initial review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the committee responsible for the evaluation of safety issues for human medicines, which will make a set of recommendations. EMA defines referral as a procedure used to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines. In a referral, the EMA is requested to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the European Union (EU). The medicine, or the class of medicines, is 'referred' to the Agency so that it can make a recommendation for a harmonized position across the EU. Procedure under Article 20 is triggered for medicines that have been authorized via the centralized procedure in case of quality, safety or efficacy issues36.
The agency further said that doctors in the EU will be contacted directly in the coming days with further information. The agency said that it will communicate further as necessary.
EMA recommends immediate suspension and recall of multiple sclerosis medicine Zinbryta
Further, on March 07, 2018, the European Medicines Agency (EMA) recommended immediate suspension and recall of the multiple sclerosis medicine Zinbryta (daclizumab beta)37 following 12 reports of serious inflammatory brain disorders worldwide, including encephalitis and meningoencephalitis, of which three were fatal. A preliminary review of the available evidence indicates that immune reactions observed in the reported cases may be linked to the use of Zinbryta. Zinbryta may also be linked to severe immune reactions affecting several other organs.
To protect patients' health, EMA is recommending immediate suspension of the medicine's marketing authorization in the EU and a recall of batches from pharmacies and hospitals. The agency said that 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. EMA's recommendation to suspend Zinbryta and recall the product was also sent to the European Commission for a legally binding decision.
The agency also released following information for patients and healthcare professionals:
Information for patients
- If you are being treated with Zinbryta, contact your doctor to discuss your treatment.
- Do not take another injection of Zinbryta.
- Tell your doctor immediately if you have or experience symptoms such as persistent high temperature, severe headache, nausea (feeling sick), tiredness, yellowing of the skin or eyes and vomiting. These could be signs of a reaction to Zinbryta.
- Your doctor will carry out regular blood tests for up to 6 months after stopping treatment to check for side effects.
- If you are in a clinical study with Zinbryta, contact the doctor treating you in the study.
Information for healthcare professionals
- Do not start any new patients on Zinbryta.
- Contact your patients currently being treated with Zinbryta as soon as possible and stop their treatment. Consider alternative treatments as appropriate.
- Patients stopping treatment should be monitored at least monthly or more frequently, as clinically indicated, for up to 6 months after the last dose of Zinbryta.
- Advise patients to immediately report symptoms of liver injury such as prolonged fever, severe headache, tiredness, jaundice, nausea or vomiting. These reactions can occur for 6 months after treatment has been stopped.
- A recall of Zinbryta will take place from pharmacies and hospitals across the EU.
About Daclizumab (Zinbryta)
Zinbryta (Daclizumab) was authorized in 2016 for treating relapsing forms of multiple sclerosis. Following a 2017 review of the medicine's effects on the liver, the use of the medicine was restricted to patients who have tried at least two other disease-modifying treatments and cannot be treated with any other multiple sclerosis treatments. Till date, over 8,000 patients have been treated with Daclizumab worldwide. Majority of EU patients have been treated in Germany.
Conclusion:
Due to safety concerns and to protect patients from the adverse effects of Daclizumab, the EMA has recommended immediate suspension and recall of this medicine from the European Union. EMA's recommendation to suspend Zinbryta and recall of the product is being sent to the European Commission for a legally binding decision.
Footnotes
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