PDF) Clinical evaluation of natalizumab for formulary consideration
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The U.S. Food and Biologic Administration said Wednesday it accustomed a new biologic from Biogen Idec to ascendancy assorted sclerosis in adults with hard-to-treat forms of the disease.

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The twice-a-day capsules, alleged Tecfidera, action a new advantage for assorted sclerosis, a debilitating ache in which the anatomy attacks its own afraid system. U.S. -based Biogen Idec already sells two added drugs for the disease, but both crave injections.

There is no cure for assorted sclerosis and best patients acquaintance relapses of symptoms, including accident of balance, weakness in accoutrements and legs, and blurred vision. Over time patients usually become weaker and beneath coordinated. More than 2 actor bodies common accept the disease, with about 400,000 of them in the U.S., according to Biogen.

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The FDA said it accustomed Tecfidera based on two studies assuming patients demography the biologic had beneath relapses than patients demography a copy pill.

The approval gives Biogen a new artefact in an more awash acreage of assorted sclerosis drugs.

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The biotech drugmaker already sells the once-a-week assorted sclerosis bang Avonex. It additionally markets the once-a-month bang Tysabri through a affiliation with Elan Corp. PLC of Ireland. However, Tysabri’s astringent ancillary furnishings accept concise its use.

Tecfidera is advised to be taken orally, which could accomplish it a adopted advantage for patients and doctors.

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A Biogen controlling said Wednesday that its three drugs would be acclimated to amusement altered groups of patients.

“Multiple sclerosis is a analytic circuitous ache and we anticipate there are a lot of needs out there,” said Tony Kingsely, a carnality admiral at Biogen. “By accepting three drugs out there I anticipate we can abode a lot of those needs.”

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Kinglsey said the aggregation will advertise the appraisement of the biologic back it begins aircraft in the aing week.

Novartis launched the aboriginal pill-based assorted sclerosis drug, Gilenya, in October 2010. Sanofi won FDA approval for a additional pill, its biologic Aubagio, aftermost September.

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The top-selling biologic for the ache common is Copaxone, which is fabricated by Teva Pharmaceutical Industries. That bang had sales of about $4 billion aftermost year, according to Teva’s latest banking report.

Avonex and Tysabri had anniversary sales of $2.7 billion and $1.5 billion in 2011, the best contempo year for which Biogen has appear anniversary sales.

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Biogen Idec Inc. shares rose $5.59, or 3.2 percent, to aing Wednesday at $182.68.

Explore further: Leukoencephalopathy accident factors ID’d for MS biologic

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