Tags: FDA | Biogen | Drug | Tecfidera

FDA Approves Biogen's MS Drug, Tecfidera

Wednesday, 27 Mar 2013 04:07 PM

U.S. regulators have approved a new multiple sclerosis drug made by Biogen Idec Inc. that is widely expected to become the No. 1 oral treatment for the disease, with annual sales of more than $3 billion.

The drug, Tecfidera, activates a chemical pathway in the body known as Nrf2 which helps protect nerve cells from damage and inflammation. It is expected to be launched within days.

Multiple sclerosis is a chronic condition which attacks the central nervous system and can lead to numbness, weakness, paralysis and blindness. It affects more than 2.1 million people worldwide, according to the National Multiple Sclerosis Society.

The U.S. Food and Drug Administration said on Wednesday that the drug may decrease a patient's white blood cell. White blood cells help protect the body from infection, and while no significant increase in infections was seen during clinical trials of the drug, the agency recommended patients have their white blood cell count assessed before treatment and once a year after that.

Biogen already sells the MS drugs Avonex and Tysabri, which together account for about 30 percent of the market. Teva Pharmaceutical Industries Ltd's drug Copaxone is the current market leader, with a roughly 29 percent share and annual sales last year of more than $4 billion.

Unlike Copaxone, Avonex and Tysabri, which are injected or infused, Tecfidera comes in the more convenient form of a pill. As such, it will compete with Novartis AG's MS pill Gilenya, which, though first to market, has been dogged by heart safety concerns. Gilenya holds an 8.5 percent share of the market and generated worldwide sales of $1.2 billion last year.

Biogen's shares on Wednesday rose 3.2 percent to end at $182.68, according to unofficial closing figures in New York.
 

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U.S. regulators have approved a new multiple sclerosis drug made by Biogen Idec Inc. that is widely expected to become the No. 1 oral treatment for the disease, with annual sales of more than $3 billion.
FDA,Biogen,Drug,Tecfidera
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2013-07-27
Wednesday, 27 Mar 2013 04:07 PM
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