European regulators have agreed to review Biogen and AbbVie’s application to market Zinbryta (daclizumab; high yield process) for relapsing-remitting forms of multiple sclerosis.
The application is centred on data from two clinical trials showing that once-monthly subcutaneous administration of Zinbryta was linked with a statistically-significant reduction in the annual relapse rate of MS.
In the DECIDE trial, this reduction was 45% compared with Avonex, while in the SELECT study it was 54% versus placebo.
On the safety side, more serious skin reactions and raised liver enzyme levels were reported in patients taking the drug.
The filing and validation of Zinbryta's submission are "important milestones and mean this investigational treatment is one step closer to potentially becoming available to MS patients who may benefit from its novel profile,” said Gilmore O’Neill, who heads up Multiple Sclerosis Research and Development at Biogen.