Amid reports that Zinbryta (daclizumab) has caused severe and unexpected side effects on the brain, the multiple sclerosis drug has been pulled from the market just two years after it was approved for use.
Zinbryta was originally intended as an alternative to existing multiple sclerosis drug treatment options on the market but quickly lost an audience after early warnings that the drug was associated with severe liver injuries and immune-mediated disorders.
WIth at least three reports of deaths related to the drug and a dozen reports of adverse events, some are wondering whether patients may have a case against the makers of Zinbryta.
In March 2018, pharmaceutical companies Biogen and AbbVie announced they were voluntarily pulling Zinbryta from the global market. In a statement, the companies said they believed that “characterizing the complex and evolving benefit/risk profile of ZINBRYTA will not be possible going forward given the limited number of patients being treated.”
Alfred Sandrock, the executive vice president and chief medical officer at Biogen, said patient safety was a priority of the companies and the withdrawal was in the best interest of patients.
The decision came around the same time the European Medicines Agency (EMA) announced it was reviewing the drug after it was reported to have caused seven cases of serious inflammatory brain disorders in Germany and one in Spain. The EMA is a regulatory agency for European countries and plays a similar role as the U.S. Food and Drug Administration (FDA) in reviewing and approving drugs.
By March 6, 2018, the EMA recommended the immediate suspension and recall of Zinbryta after more cases of serious inflammatory brain disorders were reported. At least 12 cases were reported. Three were fatal.
The reports dealt with cases of encephalitis and meningoencephalitis. The symptoms of inflammation of the brain can include seizures, headaches, fever, change in behavior, stroke, and even death, according to the National Institute of Neurological Disorders and Stroke.
Before withdrawal from the market, Zinbryta was prescribed to an estimated 8,000 patients.
The drug was first approved by the FDA in May 2016 for treatment of adults with relapsing forms of multiple sclerosis. At the time of its approval, Billy Dunn of the FDA’s Center for Drug Evaluation and Research said it was “an additional choice to who may require a new option for treatment.”
Multiple sclerosis is an inflammatory autoimmune disease that affects the central nervous system and disrupts communication between the brain and the body. It occurs when the immune system targets the brain, spinal cord, and optic nerves. The cause of multiple sclerosis remains unknown.
Zinbryta was designed to work specifically in patients with relapsing forms of multiple sclerosis.
According to the National Multiple Sclerosis Society, the relapsing form of the disease is the most common. It is characterized by clearly defined attacks of symptoms that are followed by periods of recovery. During the recovery periods, the disease has no apparent progression. However, as relapses continue, the recovery becomes incomplete and the disease worsens.
In 2017, Zinbryta generated $53 million in revenues for Biogen, according to Genetic Engineering & Biotechnology News. However, it was predicted to have reached $500 million in annual sales when it was introduced in 2016.
Part of the reason for the poor sales and less than expected use was Zinbryta’s association with severe side effects.
The prescribing information sheet for Zinbryta warned of common side effects like upper respiratory tract infections, rashes, flu, eczema, depression, and sore throat. But it was the more severe side effects that made taking Zinbryta such a risk.
When Zinbryta was first released, it included a black box warning, which is the strictest warning put on a label by the FDA. The label warned that the drug can cause severe liver injury, such as autoimmune hepatitis and liver failure.
“Fatal cases have occurred,” the label warns. “Liver injury, including autoimmune hepatitis and acute liver failure, can occur at any time during treatment with ZINBRYTA, with cases reported up to 5 months after the last dose of ZINBRYTA.”
Along with warnings of liver injury, Zinbryta was known to cause various immune-mediated disorders. These include disorders such as skin reactions, lymphadenopathy, immune-mediated colitis, and other serious conditions.
With the elevated dangers of Zinbryta, the FDA required the makers to make the drug only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS).
The Zinbryta REMS Program had specific requirements. Most notably, prescribers and pharmacies dispensing the drug had to be certified by the program. Patients also had to enroll in the program and comply with monitoring requirements.
REMS is a drug safety program required by the FDA for drugs with serious safety concerns. The program helps reinforce proper medication use but is not meant to stop all adverse events.
“Rather, REMS focus on preventing, monitoring and/or managing a specific serious risk by informing, educating and/or reinforcing actions to reduce the frequency and/or severity of the event,” according to the FDA.
By November 2017, the EMA added similar restrictions on which patient groups could receive Zinbryta after clinical trials found 1.7% of patients receiving the drug had a serious liver reaction.
Zinbryta was designed to be administered through subcutaneous injection by a patient at home once a month.
Patient reviews on MS forums around the web were often hopeful as the drug remained a last resort for patients who had used at least two different drugs to treat multiple sclerosis drugs but did not see results.
However, the dangers associated with Zinbryta were so high that the drug was polarized. For example, in 2016, the National Institute for Health and Care Excellence (NICE) recommended against using the drug in England and Wales during the first stage of its review process.
The MS Society in the UK expressed disappointment in that decision and advocated for Zinbryta to be used in treatment.
Although Zinbryta was pulled from the market, thousands of people around the world have already taken the drug. At least a dozen people have suffered from severe adverse events, including death, from previously unknown side effects.
Drug makers often come under fire from patients for failing to create and market a safe product for consumers.
With lawyers around the country investigating whether patients have a case against Biogen and AbbVie for failing to warn patients of potentially lethal inflammatory brain disorders associated with the drug, it is possible there will be lawsuits in the future.
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