Approval Supported by Largest and Longest Head-to-Head Global Phase 3 Study Conducted in Multiple Sclerosis (MS)
ZINBRYTA™ Significantly Reduced Multiple Measures of Disease Activity in Patients with Relapsing Remitting MS
Health Canada has approved ZINBRYTA™ (daclizumab beta), a new once-monthly, self-administered, subcutaneous treatment for adult patients with active relapsing remitting multiple sclerosis (RRMS), who have had an inadequate response to, or are unable to tolerate, one or more therapies indicated for the treatment of multiple sclerosis, Biogen (BIIB) and AbbVie (ABBV) announced today.
“ZINBRYTA™ is the first once-monthly, self-administered treatment for MS, and it demonstrated superior efficacy over a widely used interferon. Clinical data showed ZINBRYTA™ significantly reduced relapses and brain lesions for up to three years compared to AVONEX® (interferon beta-1a) intramuscular injection, and has a positive benefit-risk profile with monthly patient monitoring,” said Lisa Hickey, Vice President and Managing Director at Biogen Canada Inc. “Not only does the Health Canada approval reflect our long-term commitment to our patients, it provides people living with MS a further treatment choice to meet their diverse and evolving needs.”
The Health Canada approval of ZINBRYTA™ is based on results from two clinical trials, including DECIDE, the largest and longest head-to-head global Phase 3 clinical trial conducted in MS. The Phase 2b SELECT and Phase 3 DECIDE studies were global, randomized, double-blind, controlled studies that involved approximately 2,400 people living with relapsing MS. Some patients in DECIDE were treated for up to three years.
In DECIDE and SELECT, ZINBRYTA™ significantly reduced the annualized relapse rate (ARR), the primary endpoint of the studies, by 45 percent compared to AVONEX® up to 144 weeks and by 54 percent compared to placebo at 52 weeks (both p<0.0001), respectively.
Results from DECIDE showed that ZINBRYTA™ demonstrated superior efficacy across multiple measures of MS disease activity (relapses and MRI) compared to AVONEX®, including a significant reduction in the mean number of new or newly enlarging T2-hyperintense lesions by 54 percent compared to AVONEX® at 96 weeks (p<0.0001).
The ZINBRYTA™ Product Monograph includes a Serious Warnings and Precautions box for the risk of hepatic injury, including autoimmune hepatitis, and other immune-mediated disorders such as skin reactions, lymphadenopathy, autoimmune hemolytic anemia and gastrointestinal disorders can occur in patients treated with ZINBRYTA™.1 Because of these risks, access to ZINBRYTA™ in Canada is available through a controlled distribution program called Biogen ONE® Support Program. Only prescribers and pharmacies registered with the program are able to prescribe and dispense ZINBRYTA™. In addition, ZINBRYTA™ can only be dispensed to patients who are registered in the Biogen ONE® Support Program. Patients will be informed about the risks of ZINBRYTA™ and how to meet the conditions of the Biogen ONE®Support Program, including compliance with monthly monitoring and assessment of liver enzymes before the next dose of ZINBRYTA™.
“MS affects each person differently, so having additional therapeutic options to address their needs throughout the course of this long term disease is very important news,” said Marcelo Kremenchutzky, MD, FRCPC, FAAN, Chapman Chair in MS Clinical Research at London Health Sciences Centre and Associate Professor in Neurology at Western University, London, Ontario. “Daclizumab beta provides a meaningful new option for the treatment of people with MS, with demonstrated efficacy and convenient once-monthly dosing.”
ZINBRYTA™ is thought to work differently from other disease-modifying therapies by binding to CD25, a subunit of the interleukin-2 (IL-2) receptor found on activated lymphocytes, cells believed to underlie the biology of MS. Total lymphocyte, T and B cell counts decreased less than 10 percent from baseline during the first year of treatment. The effects on total lymphocyte counts returned to baseline within approximately eight to 12 weeks after the last dose of ZINBRYTA™.