FDA Approves New Treatment for Relapsing Forms of Multiple Sclerosis

The FDA has approved daclizumab (Zinbryta) as a treatment for adults with relapsing forms of multiple sclerosis.

Zinbryta is a long-acting injection that is self-administered by the patient every month.

The FDA's approval was based on results from 2 clinical trials. In the first trial, Zinbryta was compared with Avonex in 1841 patients over the course of 144 weeks. Those who used Zinbryta had fewer clinical relapses.

The second trial looked at Zinbryta vs placebo in 412 patients for 52 weeks. Again, patients experienced fewer relapses while taking Zinbryta when compared with the other group.

“Zinbryta provides an additional choice to patients who may require a new option for treatment,” said Billy Dunn, MD, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release.

The FDA noted that Zinbryta should generally be used only in patients who do not respond well to 2 or more multiple sclerosis drugs, since the newly approved drug can lead to liver injury and serious immune conditions. The treatment’s boxed warning discusses severe liver injury, as well as conditions like noninfectious colitis, skin reactions, and enlargement of the lymph nodes.

Zinbryta, which was co-developed by Biogen and AbbVie, is only available under the Risk Evaluation and Mitigation Strategy program.

Health care professionals should conduct blood tests to monitor patients’ liver function before taking the medication, monthly, and up to 6 months after the last dose.

Some of the most common adverse effects associated with Zinbryta include cold symptoms, upper respiratory tract infection, rash, influenza, and dermatitis. When compared with placebo, Zynbryta was linked with with depression, rash, and increased alanine aminotransferase.

Multiple sclerosis is a chronic autoimmune disease that impacts the central nervous system. It disrupts communication between the brain and other parts of the body. Episodes of worsening function, or relapses, may fall in between recovery periods.