Biogen Idec and development partner AbbVie Inc. received Health Canada's approval for ZINBRYTA, a subcutaneous treatment for adult patients with active relapsing remitting multiple sclerosis.
The approval is based on results from phase 2b and phase 3 clinical trials, which showed that the drug significantly reduced the annualized relapse rate by 45% compared to Biogen's AVONEX up to 144 weeks and by 54% compared to placebo at 52 weeks, respectively.
The phase 3 study also showed that ZINBRYTA had superior efficacy across multiple measures of MS disease activity compared to AVONEX, including a significant reduction in the mean number of new or newly enlarging T2-hyperintense lesions by 54% compared to AVONEX at 96 weeks.
The U.S. FDA and European Committee for Medicinal Products for Human Use of the European Medicines Agency, and the Australian Therapeutic Goods Administration recently granted approval for ZINBRYTA. The drug is also currently under regulatory review in Switzerland.