FDA-Approved Medications: New Data
WITHDRAWN FROM MARKET
Company: Biogen and AbbVie
- 150 mg given via subcutaneous injection once monthly
- Approved in 2016 for RMS; voluntarily withdrawn from market in March 2018
In early March 2018, Biogen and AbbVie announced the voluntary worldwide withdrawal of Zinbryta® for relapsing MS. The move came after the European Medicines Agency had raised new safety concerns related to reports of inflammation of the brain or its surrounding tissues (inflammatory encephalitis and meningoencephalitis) among people taking the immune-modulating therapy. Because of previously identified risks, the medication generally had been reserved for use in people who had experienced an inadequate response to two or more other MS medications.10
To minimize the potential for confusion or disruption of care in individuals taking Zinbryta, the FDA worked closely with the medication’s manufacturers to ensure the medication’s withdrawal from the market.
As this MS Research Update was published, the manufacturers of Zinbryta planned to have the medication available as needed until April 28, 2018. People taking Zinbryta were told to contact their doctor for instruction on stopping Zinbryta and switching their medication, and to immediately tell him or her about any new or unexplained symptoms.10, 11
The withdrawal of Zinbryta underscores the fact that clinical trials, no matter how large and rigorously performed, cannot identify all of the safety issues that may emerge when a medication moves to widespread use following approval by the FDA or regulatory agencies in other countries. At the same time, clinical trials did reveal other safety considerations that prompted the medication’s FDA-approved indication to note that it generally should be used only when patients had not had a satisfactory response to at least two other medications. Similarly, it would appear that the post-approval surveillance system worked well in flagging rare but serious conditions that may be associated with the use of Zinbryta.