Only two years after Zinbryta was approved by the U.S. Food and Drug Administration for treatment of adults with relapsing multiple sclerosis, the drug was removed from global markets after reports of severe side effects like brain inflammation.
The voluntary worldwide withdrawal of Zinbryta was issued by makers Biogen and AbbVie. The companies announced the decision the same day as the European Medicines Agency announced it was looking into at least seven cases of inflammatory encephalitis and meningoencephalitis.
The recall is now prompting lawyers around the country to investigate whether the thousands of individuals prescribed Zinbryta may be eligible for financial compensation from the manufacturers.
What is Zinbryta?
Zinbryta, also known by its generic name daclizumab, is a drug first approved by the FDA in May 2016 to treat adults with relapsing forms of multiple sclerosis.
According to the National Multiple Sclerosis Society, multiple sclerosis is a disease that affects the central nervous system and disrupts the flow of information within the brain and between the brain and the body.
Relapsing forms of the disease are the most common and are characterized by attacks following periods of recovery. The relapses often feature new or increasing neurologic symptoms, according to Johns Hopkins Medicine. Over time, recovery becomes more difficult and a progressive decline occurs.
When Zinbryta was first introduced, it was touted as an additional choice for patients.
“Zinbryta provides an additional choice to patients who may require a new option for treatment,” Billy Dunn, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, said at the time in a statement.
However, due to safety risks, Zinbryta was only recommended for use in patients who did not have positive responses to two or more other drugs designed to treat multiple sclerosis.
How Does Zinbryta Work?
Zinbryta is a humanized monoclonal antibody that makes changes to the body’s immune system. These types of antibodies are laboratory-produced molecules designed to attack specific cells in the body.
According to the prescribing information, the exact way in which Zinbryta works to combat the effects of multiple sclerosis is unknown. However, it is thought to involve changes of the interleukin-2 receptor (IL-2R).
The drug is administered via injection under the skin. The recommended dose is 150 milligrams once a month. The most common sites for injection include the thigh, abdomen, and back of the upper arm.
Common Zinbryta Side Effects
Like nearly every drug, Zinbryta has possible side effects. Just some of the most common side effects of Zinbryta include (but are not limited to):
- Upper respiratory tract infection
- Stuffy nose
- Swollen lymph nodes
- Sore throat
Zinbryta REMS Program
While less severe side effects are common, Zinbryta is also known to have greater risks. These additional side effects include liver injury and immune conditions.
Due to those elevated risks, Zinbryta came with a black boxed warning — the strongest label warning issued by the FDA. The label warned prescribers that the drug could cause severe liver injury in which fatalities have occurred.
The boxed warning also notified prescribers of incidence of immune-mediated disorders, such as “skin reactions, lymphadenopathy, immune-mediated colitis, and other serious conditions.” These side effects were observed in 5% of patients treated with Zinbryta.
Because of the risks of hepatic injury and immune-mediated disorders, Zinbryta was only available through a Risk Evaluation Mitigation Strategy (REMS) program called the Zinbryta REMS Program.
A REMS is required by the FDA in some drugs to ensure that the benefits of prescribing a drug outweigh the risks. The drug makers will create the REMS program, and the FDA approves it. That means for the drug to be approved for use in an individual, the prescriber, patient, and pharmacist must meet very specific requirements.
For the Zinbryta REMS Program, there are three notable requirements. A prescriber must be certified in the program. A patient must be enrolled in the program and comply with ongoing monitoring. A pharmacist must be certified with the program and may only dispense the drug to authorized patients.
EMA Conducts Zinbryta Patient Review
In June 2017, the European Medicines Agency (EMA), the European equivalent of the FDA, initiated a review of Zinbryta. It was brought about after concerns over the safety of the drug.
The review concluded in November 2017 with the EMA implementing further restrictions to reduce the risk of liver damage in patients taking Zinbryta.
According to the EMA, “The review found that unpredictable and potentially fatal immune-mediated liver injury can occur during treatment with Zinbryta and for up to 6 months after stopping treatment.” Clinical trials revealed 1.7% of patients treated with Zinbryta had a serious liver reaction.
The restriction meant that only patients who had tried at least two other disease-modifying treatments (DMTs) and could not be treated with any other DMTs should be prescribed Zinbryta. Healthcare professionals were encouraged to review all patients carefully and monitor them closely for up to six months following treatment.
Zinbryta Withdrawn From Market After Reports of Deaths
Despite the stronger restrictions, Zinbryta continued to be administered until March 2018.
On March 2, 2018, Biogen and AbbVie announced a voluntary worldwide withdrawal of the drug after concluding they would no longer be able to create a benefit/risk profile because of the limited number of patients being treated.
“Biogen believes the voluntary worldwide withdrawal of ZINBRYTA, a treatment for relapsing multiple sclerosis, is in the best interest of patients,” Alfred Sandrock, executive vice president and chief medical officer at Biogen, said in a statement at the time. “Biogen and AbbVie continue to prioritize patient safety and the care of multiple sclerosis patients worldwide.”
The announcement came the same day as the EMA started an “urgent review” of the drug following eight cases of serious inflammatory brain disorders. These brain disorders included encephalitis and meningoencephalitis.
Four days later, the agency recommended the immediate suspension and recall of the medication. It found 12 reports of inflammatory brain disorders around the world. Three of the cases were fatal.
Zinbryta Lawsuits May Be Coming
Zinbryta carried risks of liver injury that were prominently marked on the label since the beginning, but there was no information on the side effects that reportedly killed at least three people and severely injured several others.
Patients who were prescribed Zinbryta may not have been aware of the potential symptoms that could affect the brain, such as inflammation. With lawyers around the country beginning to review whether patients are entitled to compensation over claims that the makers failed to warn of serious side effects, it is possible patients will begin filing lawsuits against Biogen and AbbVie.