Zynbrita a New Treatment Available for Relapsing Multiple Sclerosis

In the News: June 2016 - FDA News & Updates

On May 27, 2016, the FDA approved daclizumab (Zinbryta; Biogen), a long-acting injection, for the treatment of adults with relapsing forms of multiple sclerosis (MS). Daclizumab can be self-administered by the patient.  Daclizumab is recommended for patients who had an inadequate response to ≥2 drugs for MS, because of its safety profile.

Daclizumab was approved for relapsing MS based on 2 double-blind, controlled clinical trials that used 150 mg daclizumab, administered once monthly. The first trial compared daclizumab with interferon beta-1a (Avonex) in 1841 patients with relapsing MS. The daclizumab group had a 45% relapse reduction and a 54% reduction in new or enlarging T2- hyperintense lesions versus the interferon beta-1a group. The second study compared daclizumab with placebo in 412 patients with relapsing MS. Daclizumab had a 54% relapse reduction, a 57% reduction in disease progression, a 70% reduction in new or newly enlarging T2-hyperintense lesions, and a 69% reduction in new T1 Gd-enhancing lesions versus interferon beta-1a. Of note, 81% of patients using daclizumab were relapse free compared with 64% in the interferon beta-1a group.

The most common adverse events reported with daclizumab in the 2 studies included nasopharyngitis, upper respiratory tract infection, eczema, rash, influenza, dermatitis, depression, oropharyngeal pain, lymphadenopathy, and increased alanine aminotransferase levels.

Daclizumab was approved with a boxed warning about the serious risk for hepatic injury, including autoimmune hepatitis and other immune-mediated disorders. Transaminase and bilirubin levels should be evaluated before starting daclizumab therapy, and patients should be monitored monthly and up to 6 months after stopping therapy. Daclizumab is distributed through a Risk Evaluation and Mitigation Strategy program only.

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In the News: June 2016 published on June 20, 2016 in FDA News & Updates
Last modified: June 20, 2016
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