Biogen Idec seeking approval from the FDA for an injectable multiple sclerosis drug

By Robert Weisman, Globe Staff

Biogen Idec Inc., which cemented its place as the dominant multiple sclerosis drug maker in March when it won US approval to sell an MS pill, said Tuesday it has applied to the Food and Drug Administration to market a third injectable MS drug.

The drug, called Plegridy, is a new version of the Weston biotechnology companys first -- and hugely successful -- MS treatment, Avonex. While both drugs have the same active ingredient, interferon beta, Biogen Idec has attached a polymer called polyethylene glycol, or peg, to Plegridy that increases the exposure of the drug, allowing patients to take doses less frequently.

And unlike Avonex and other MS drugs received through intramuscular injections, Plegridy would be administered subcutaneously, or under the skin, which is less painful.

We see this as part of our commitment to MS patients, said Douglas E. Williams, Biogen Idecs executive vice president of research and development. Its a convenient version of a drug thats been on the market for many years and has a track record of safety and efficacy.

Williams said Plegridy met its goals of reducing the diseases effects -- including relapses and worsening disabilities -- in a late-stage clinical trial where it was given to patients every other week rather than the weekly dosing used for those taking Avonex and other interferon drugs.

MS is a chronic autoimmune disorder that affects the central nervous systems of about 400,000 people in the United States and 2.5 million globally. It disrupts communication between the brain and other parts of the body. Most people experience their first symptoms between age 20 and 40, and over time suffer from muscle weakness, loss of balance, and a progressive decline in physical functions.

In addition to Avonex, Biogen Idecs other MS drugs include the Tecfidera pill and Tysabri, which is often prescribed for patients with more severe cases of the disease.

If federal regulators approve Plegridy, company officials believe many doctors will shift MS patients to the new treatment from not only Avonex but also competing injectable treatments such as Rebif, marketed by Rockland-based EMD Serono, and Copaxone, sold by the Israeli drug company Teva Pharmaceutical Industries Ltd.

Williams said Biogen Idec will also apply for approval of Plegridy with European regulators in the coming weeks.

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Biogen Idec seeking approval from the FDA for an injectable multiple sclerosis drug