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FDA approves Biogen Idec's long-acting MS therapy

Plegridy gets US nod just weeks after EU approval

Biogen Idec building 

After a short delay, the US FDA has approved Biogen Idec's new multiple sclerosis therapy Plegridy, a few weeks after the drug was given the nod in Europe.

Plegridy (peginterferon beta-1a) is a long-acting version of Biogen Idec's $3bn-a-year Avonex that has been a mainstay of MS therapy for years but is facing increased competition in the marketplace.

The new drug is dosed once every two weeks - compared to once a week for Avonex - and is the first pegylated version of interferon beta to be approved for marketing in the US, said Biogen Idec in a statement.

The FDA had been due to deliver a verdict on the Plegridy marketing application in March, but extended the review time by three months.

The approval is based on the results from the first year of the phase III ADVANCE study which demonstrated that Plegridy met its objectives by significantly reducing disease activity in MS patients, cutting relapses, disability progression and brain lesions compared to placebo.

The new long-acting formulation will give Biogen Idec a competitive advantage over interferon rivals such as Bayer's Betaferon/Betaseron (interferon beta-1b) and Merck Serono/Pfizer's Rebif (interferon beta-1a), as well as Teva's Copaxone (glatiramer acetate), which is dosed three times a week.

Plegridy is Biogen Idec's fifth MS treatment to reach the market joining Avonex, Tysabri (natalizumab), fast-growing oral therapy Tecfidera (dimethyl fumarate) and Fampyra (fampridine).

Plegridy is not expected to reach the heights of Tecfidera - which will eventually garner peak sales of more than $6bn a year according to some analysts - but could add another $2bn-plus to Biogen Idec's increasingly strong MS franchise.

The advent of the oral therapies for MS - which include not only Tecfidera but also Novartis' Gilenya (fingolimod) and Sanofi's Aubagio (teriflunomide) - is expected to shrink the beta interferon market, although Biogen Idec chief executive George Scangos said recently that this contraction will take some years.

"As this segment of the MS market shrinks, we expect to get an increasing share of this segment as a result of the patient convenience," he said. "Plegridy represents the most significant innovation in the interferon class in over a decade."

Meanwhile, Biogen Idec and partner AbbVie are developing a new MS product called daclizumab HYP (high yield process) in phase III that could round out the portfolio with a once-monthly, subcutaneous injection.

Article by
Phil Taylor

18th August 2014

From: Sales, Regulatory



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