FDA approves Zinbryta to treat MS
The new treatment is an injection that the patients administer to themselves on a monthly basis. This long-lasting treatment is designed to last the patients the remainder of the month.
“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.
MS is an autoimmune disease that attacks the central nervous system. This inflammatory, chronic illness interrupts the communication that runs from the brain throughout the body. It is much more common among women than men.
Most patients experience MS symptoms and receive diagnosis between the ages of 20 and 40 years old. Unfortunately, MS fluctuates over time. Episodes of worse function are called relapses -- and episodes of brief recovery are called remissions -- creating an emotional rollercoaster for patients to endure. Over time, relapses grow more intense and remissions grow shorter.
Two different clinical trials have shown Zinbryta to be effective. The first trial was a comparison of Avonex and Zinbryta, involving 1,841 participants for 114 weeks. The other trial was a comparison of Zinbryta with a placebo, involving 412 participants for 52 weeks.
Organizations in this story
U.S. Food and Drug Administration (FDA) 10903 New Hampshire Ave Silver Spring, MD - 20903