Health Canada has approved Zinbryta (daclizumab) as a treatment for adults with active relapsing-remitting multiple sclerosis (RRMS), Biogen and AbbVie announced. Zinbryta is a long-acting injection therapy, self-administered monthly, for patients who have had an inadequate response to at least two other MS therapies.
“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,” Lisa Hickey, vice president and managing director at Biogen Canada, said in a news release.
Zinbryta’s approval by Health Canada was based on data from the global Phase 3 DECIDE (NCT01064401) and Phase 2b SELECT (NCT00390221) clinical trials, in which Zinbryta 150 mg, administered once per month, improved the clinical outcomes of MS disease activity in 2,400 patients with relapsing MS, in comparison to Avonex (30 mcg administered every week) and a placebo.
Specifically, in both clinical trials, Zinbryta significantly reduced by 45 percent the annualized relapse rate (ARR) compared to Avonex at up to 144 weeks, and by 54 percent compared to placebo at 52 weeks.
In the DECIDE trial, Zinbryta also demonstrated superior efficacy to Avonex across various measures of MS disease activity (as seen in relapses and by MRI), including a 54 percent reduction in the mean number of new or newly enlarging lesions (T2-hyperintense lesions) at 96 weeks.
Zinbryta is associated with serious safety risks, including liver injury and the possibility of autoimmune hepatitis, and with immune disorders like non-infectious colitis, skin reactions, and enlarged lymph nodes (lymphadenopathy). Because of these risks, the drug’s Product Monograph includes a Serious Warnings and Precautions box regarding possible side effects. Access to the drug in Canada will be available through a Biogen controlled distribution program, called Biogen ONE Support Program, and patients wishing to use the treatment must be registered in that program, the company said in its release.
“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,” Marcelo Kremenchutzky, MD, Chapman Chair in MS Clinical Research at London Health Sciences Centre, and an associate professor in Neurology at Western University in Ontario, said. “Daclizumab beta provides a meaningful new option for the treatment of people with MS, with demonstrated efficacy and convenient once-monthly dosing.”
Zinbryta is a humanized monoclonal antibody that binds to the receptor subunit CD25 of interleukin-2 (IL-2), which is highly expressed in immune T-cells. These immune cells are overly expressed in MS, and Zinbryta is thought to deplete the activated T-cells and increase other cells that regulate the immune response (namely NK cells). The U.S. Drug and Food Administration (FDA) approved Zinbryta, under a similar indication, in May 2016.
“ZINBRYTA™ has a different target in the immune system compared to other MS therapies,” Kremenchutzky said. “ZINBRYTA™ provides both patients and clinicians an additional and distinct treatment option to consider. Having options is critical when the course of MS can be so different from patient to patient.”