A little less than two years after the Zinbryta FDA approval, drugmakers announced they were withdrawing the MS drug from the market.

The popular multiple sclerosis drug received its Zinbryta FDA approval in May 2016. Now, less than two years later, in March 2018, the drug manufacturers Biogen and Abbvie released an announcement that they would be pulling their drug from the market.

The original Zinbryta FDA approval announcement explained that there was now a new option for multiple sclerosis patients who had tried other drugs that did not work.

Zinbryta, according to the Zinbryta FDA approval announcement, “provides an additional choice to patients who may require a new option for treatment.” It was approved for “the treatment of adults with relapsing forms of multiple sclerosis (MS)… [and] is a long-acting injection that is self- administered by the patient monthly.”

The Zinbryta FDA approval announcement explains that “MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body.” It is most commonly diagnosed in women rather than men and is the most common form of neurological disability in young adults.

According to the Zinbryta FDA approval announcement, those with MS experience episodes of worsening symptoms and then periods of recovery. When this happens over a long period of time, the relapses may not be complete. This may result in greater disability because of the disorder.

The Zinbryta FDA approval announcement states that Zinbryta’s effectiveness was seen in two different clinical trials. “One trial compared Zinbryta and Avonex in 1,841 participants who were studied for 144 weeks. Patients on Zinbryta had fewer clinical relapses than patients taking Avonex. The second trial compared Zinbryta with placebo and included 412 participants who were treated for 52 weeks. In that study, those receiving Zinbryta had fewer relapses compared to those receiving placebo.”

Severe Side Effects Reported

Even with Zinbryta’s seeming success with treating multiple sclerosis symptoms and the Zinbryta FDA approval, there have been reports of a serious condition associated with the use of the drug.

Encephalitis, a serious brain condition, has been connected with the use of Zinbryta. At least twelve cases of Zinbryta-related encephalitis have been reported. Of the twelve, there have been three reported fatalities.

In March of this year, because of the encephalitis reports, drug manufacturers Biogen and Abbvie put out a voluntary recall on their medication.

The U.S. Food and Drug Administration (FDA) reported, “Recently, the European Medicines Agency announced a recall of Zinbryta following 12 reports of serious inflammatory brain disorders worldwide.” They state that they are aware of these reports and are conducting reviews of any similar events.

The FDA also encourages those who are taking Zinbryta for their MS to discuss it with their doctors before stopping any drugs. It is not recommended to stop Zinbryta without a doctor’s care.

If you or someone you love has taken Zinbryta may have suffered from encephalitis or other serious side effects, you may benefit from speaking with an experienced attorney.