European Commission approves Zinbryta to treat relapsing forms of multiple sclerosis

European Commission approves Zinbryta to treat relapsing forms of multiple sclerosis

The European Commission (EC) has approved Zinbryta (daclizumab) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS).

Zinbryta, which is being developed by Biogen and AbbVie, is a once-monthly, self-administered, subcutaneous injection.

It has an immunomodulatory mechanism of action that regulates inflammation without depleting the immune system and immune cell effects are reversible within six months.

In clinical trials, Zinbryta showed superior efficacy in relapse reduction and MRI, key measures of MS disease activity, compared to Avonex (interferon beta-1a) intramuscular injection and placebo.

The EC approval of Zinbryta is supported by results from two studies, Phase 3 DECIDE and Phase 2b SELECT involving about 2,400 subjects.

In both the studies, it significantly reduced patients’ annualized relapse rate (ARR), the primary endpoint of the studies, by 45% compared to Avonex up to 144 weeks and by 54% compared to placebo at 52 weeks (both p<0.0001), respectively.

AbbVie said analyses of the studies demonstrated the consistent effect of Zinbryta relative to placebo and Avonex across several subgroups of patients defined by demographic and MS disease characteristics.

Zinbryta selectively binds to the high-affinity interleukin-2 (IL-2) receptor subunit (CD25), which is expressed at high levels on T-cells that become activated in people with MS.

AbbVie executive vice president, research and development and chief scientific officer Michael Severino said: “With the approval of Zinbryta in the European Union, we are providing a much needed treatment option for people living with MS.”

Zinbryta is also approved in the US and is under regulatory review in Switzerland, Canada and Australia.

Published 06 July 2016

http://regulatoryaffairs.pharmaceutical-business-review.com/

July 8, 2016 / Pharma News