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Biogen and AbbVie bag FDA approval for multiple sclerosis drug

Once-monthly, self-administered Zinbryta ‘significantly’ reduces relapse rate

The US Food and Drug Administration (FDA) has approved Biogen and partner AbbVie's once-monthly multiple sclerosis (MS) injection Zinbryta.

The US regulator sanctioned the product for the treatment of patients who have not responded to two or more MS therapies - a qualifier added due to the drug's safety profiling.

Zinbryta (daclizumab) is dosed once a month – in comparison with fortnightly and weekly for Biogen's Plegridy and Avonex, respectively - and is designed to be administered as a subcutaneous injection by the patient at home.

 Michael Severino, chief R&D and scientific officer at AbbVie, said “MS patients are in need of therapeutic choices to help manage their disease”, making Zinbryta an “important new option”.

The DECIDE and SELECT studies which served as the basis for the FDA's approval showed that Zinbryta met its primary objective in significantly reducing the annualised relapse rate (ARR) in patients by 45% when compared with Avonex (peginterferon beta-1a) at week 144.

It also demonstrated superior efficacy across multiple measures of MS disease activity, including a significant reduction in the average number of T2-hyperintense lesions by 54% at week 96, when compared with Avonex.

The new approval adds to Biogen's already sizeable stable of MS drugs on the market, which include Avonex and its long-acting version Plegridy (peginterferon beta-1a), and oral therapy Tecfidera (dimethyl fumarate).

As Biogen's largest grossing product, Tecfidera is anticipated by some analysts to reach peak sales of $6bn a year, and currently competes with Novartis' Gilenya (fingolimod) and Sanofi's Aubagio (teriflunomide).

Novartis has another MS candidate in the works, with OMB157 due to enter into phase III trials this year. The company has claimed its compound has the potential to become a “best-in-class anti-B cell therapy”. 

Commenting on Zinbryta's licensing, Alfred Sandrock, chief medical officer at Biogen, said it “reflects our long-term commitment to bringing therapies to the community that meet the diverse needs of people living with MS”.

Biogen recently launched an educational initiative 1Msg to encourage 'lost to follow-up' patients to engage with MS-specialists and take control of their disease-management.

Article by
Rebecca Clifford

1st June 2016

From: Regulatory



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