FDA approves new injectable multiple sclerosis treatment from Cambridge’s Biogen Idec - Business - The Boston Globe

FDA approves new injectable multiple sclerosis treatment from Cambridge’s Biogen Idec - Business - The Boston Globe: "FDA approves Biogen Idec’s multiple sclerosis drug

By Robert Weisman  | GLOBE STAFF   AUGUST 16, 2014"

Biogen Idec Inc. in Cambridge, Mass.

Scrambling to stay ahead of the competition in bringing multiple sclerosis drugs to market, Biogen Idec Inc. won US regulatory approval Friday to sell a new type of injectable drug that treats adults with the most common form of the neurodegenerative disease.

Food and Drug Administration regulators approved the Cambridge biotech’s application to market the drug, called Plegridy, as a longer-lasting treatment for US patients with relapsing-remitting multiple sclerosis. The approval came less than a month after the European Commission approved Biogen Idec’s medicine for sale in 28 countries across the Atlantic.

Multiple sclerosis is a chronic autoimmune disorder affecting the central nervous systems of at least 400,000 people in the United States and more than 2.3 million globally. It disrupts communication between the brain and other parts of the body, over time causing muscle weakness, loss of balance, and a progressive decline in physical functions.

Plegridy has the same active ingredient, interferon beta, as Biogen Idec’s first MS drug, Avonex, which is still being sold. But the company attached a polymer called polyethylene glycol, or peg, to Plegridy that increases the exposure of the drug, allowing patients to take doses less frequently. While Avonex has to be injected into the muscle once a week, Plegridy can be taken by injection every two weeks, administered under the skin with a prefilled auto-injector.

“As a proposition for patients, it’s a very attractive compound,” said Gilmore N. O’Neill, vice president of multiple sclerosis research and development. “It gives patients another choice.”

News of the FDA’s approval of Plegridy came after US financial markets closed Friday. But shares of Biogen Idec climbed $5.46 to $342.47, a gain of 1.6 percent, on the Nasdaq Stock Market for the day, as investors bid up shares in apparent anticipation of the approval.

The fastest growing segment of the MS drug market has been oral treatments, which have entered the market only in the past few years. But interferon drugs continue to be prescribed to treat about 50 percent of people with MS.

“Interferons have an important place,” O’Neill said. “When patients find a mechanism of action that works for them, they want to stick to it.”

Biogen Idec, the largest seller of MS medicines, also markets Tysabri for people with more severe forms of the disease, and Tecfidera, the best-selling pill for MS.

The company has not estimated the size of the market for Plegridy nor disclosed the price it will charge health insurance companies and other payers for the new treatment.

But it has said it expects the price to be similar to Avonex, which costs $59,085 per patient annually.

Biogen Idec hopes to transition many patients over time from Avonex and other first-generation interferons, some of which have to be injected three times a week, to the longer-lasting drug Plegridy.

The company has no plans to discontinue the sale of Avonex, however.

While the new Biogen Idec drug is likely to cut into sales of Avonex, company executives believe many doctors will also shift MS patients to the new treatment from competing injectable medicines such as Rebif, marketed by Rockland-based EMD Serono, and Copaxone, sold by the Israeli drug company Teva Pharmaceutical Industries Ltd.

Robert Weisman can be reached at robert.weisman@globe.com. Follow him on Twitter @GlobeRobW.

Source: http://www.bostonglobe.com/business/2014/08/15/fda-approves-new-injectable-multiple-sclerosis-treatment-from-cambridge-biogen-idec/W6kkdXYK7FPqRcFeq3rEkJ/story.html