US 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 based on data from two pivotal trials, DECIDE and SELECT, in which the drug was dosed subcutaneously every four weeks in patients, showing a statistically-significant reduction in the annual relapse rate of MS.
In the DECIDE trial, this reduction was 45% compared with Biogen’s MS therapy Avonex, while in the SELECT study it was 54% versus placebo.
“This is an important milestone in the development program for Zinbryta and moves us a step closer to potentially bringing a new treatment option to patients with MS,” said Michael Severino, AbbVie’s chief scientific officer.
Regulators in Europe are also reviewing the drug.