Biogen and AbbVie announced that the drug Zinbryta (daclizumab) has received marketing authorization by the European Commission, and is an approved treatment across most of Europe for adults with relapsing forms of multiple sclerosis (MS). Zinbryta is a self-administered, once monthly subcutaneous injection.
“Clinical data showed Zinbryta significantly reduced relapses, 24-week confirmed disability progression and new brain lesions for up to three years compared to Avonex (interferon beta-1a) intramuscular injection, providing a valuable new option for people with RMS [relapsing MS],” Professor Gavin Giovannoni, chair of Neurology, Blizard Institute, Barts and The London School of Medicine and Dentistry, said in a press release. “Zinbryta has an immunomodulatory mechanism of action (MOA) that regulates inflammation without broadly depleting the immune system, and immune cell effects are reversible within six months.
“This offers an alternative approach to treating multiple sclerosis (MS) and is an important consideration when deciding how to sequence therapies throughout the course of a patient’s disease.”
Results of two clinical trials, the Phase 2b SELECT and Phase 3 DECIDE studies, supported the Commission’s decision. Zinbryta was found to significantly reduce patients’ annualized relapse rate by 45 percent when compared to Avonex (interferon beta-1a, a drug used also in MS treatment) up to 144 weeks, and by 54 percent relative to placebo at 52 weeks.
Additionally, the trials showed Zinbryta-treated patients — compared to those given Avonex — had a significant reduction in 24-week confirmed disability progression, a significant reduction in lesions (new or newly enlarging T2 hyperintense lesions, and T1 Gd-enhancing lesions), and a significant decrease in worsening in patient-reported physical impact of MS.
“With the approval of Zinbryta in the European Union, we are providing a much needed treatment option for people living with MS,” added Michael Severino, MD, executive vice president, research and development and chief scientific officer, AbbVie. “This is an important part of AbbVie’s ongoing commitment to advancing neuroscience research specifically in the area of MS.”
Marketing authorization means that Zinbryta is now available throughout the European Union, and the European Economic Area countries of Iceland, Liechtenstein and Norway.
“Zinbryta is an important new once-monthly option for people with RMS, including those whose disease activity has been insufficiently controlled by their prior therapy,” concluded Alfred Sandrock, MD, PhD, executive vice president and chief medical officer at Biogen. “MS manifests differently in each person, with varied symptoms and progressions; therefore, it is important that people living with the disease have treatment choices to address their diverse and evolving needs.”