The withdrawal of Zinbryta due to reports of brain inflammations has left patients with fewer drugs for multiple sclerosis to work with.

According to an FDA announcement, pharmaceutical companies Biogen and Abbvie are working with the agency to withdraw Zinbryta from the worldwide market due to troubling reports of encephalitis and meningoencephalitis. The FDA stated that “no new patients will start taking Zinbryta or participate in clinical studies” and that the drug would no longer be available after April 30, 2018.

This collaboration is meant to “help ensure a well-organized withdrawal from the market in the United States, and to ensure that healthcare professionals have the information they need to carefully transition their patients using Zinbryta to another treatment,” the FDA stated.

Biogen and Abbvie announced this global market initiative on March 2, 2018, stating the multiple sclerosis treatment drugs had been linked to serious side effects like liver failure and brain inflammation conditions. According to the announcement, at least 12 cases of inflammatory brain disorders have been reported in conjunction with Zinbryta prescriptions, three of which have reportedly been fatal.

The Zinbryta initiative was started after the European Medicines Agency (EMA) investigated alleged cases of encephalitis that were linked to certain treatment drugs for multiple sclerosis.

Overview of Zinbryta Encephalitis Concern

Zinbryta was approved by the FDA on May 27, 2016, to be a treatment drug for adults with relapsing multiple sclerosis. This means that Zinbryta is typically prescribed to patients who have not responded to other treatment drugs for multiple sclerosis.

Multiple sclerosis is a debilitating disease in the brain and spinal cord, which compromises the body’s entire central nervous system. This disease causes the body’s own immune system to attack the protective layer that covers nerve fibers called myelin, which causes communication issues between the brain and spine. If left untreated, multiple sclerosis can deteriorate nerves and cause permanent mobility issues.

There is currently no cure for this disease, with patients often prescribed drugs like Zinbryta to help manage the symptoms. Zinbryta works by binding to immune cells attacking the myelin, which reduces stress on the central nervous system.

Even though Zinbryta has been vital for patients, there have been concerns surrounding the drug’s potential complications since its release. The FDA stated it was aware of the “complex safety profile of Zinbryta,” issuing a black box warning regarding potential liver damage and adverse immune reactions. The FDA also recommended that the drug should only be given to patients who have not responded to other treatment drugs for multiple sclerosis.

It was not until recently that Zinbryta’s alleged correlation to encephalitis was discovered, spurring major concern in the medical community. Encephalitis is a potentially fatal condition in which brain tissue becomes inflamed. It is often a reaction to a viral or bacterial infection.

Encephalitis symptoms typically start with flu like symptoms, which may last between two to three weeks. It is important to note that some patients may not exhibit any symptoms, symptoms of this condition can grow worse over time.