Tecfidera linked to potential PML case?

[ActiveMSers]

Shares of Biogen Idec stock plunged $17.70 to $309.07, a loss of 5.4 percent, on the Nasdaq stock exchange.

Brian Snyder/REUTERS

Shares of Biogen Idec stock plunged $17.70 to $309.07, a loss of 5.4 percent, on the Nasdaq stock exchange.

Biogen Idec Inc. said Wednesday that a patient who had taken its multiple sclerosis pill Tecfidera for more than four years died after getting a rare brain infection, sending shares of the Cambridge biotechnology company down sharply.

While the cause of death was pneumonia and there is no evidence conclusively linking it to the best-selling MS treatment, Biogen Idec spokeswoman Kate Niazi-Sai said in an interview that the company “can’t rule out Tecfidera as playing a role” in the brain infection known as progressive multifocal leukoencephalopathy, or PML.

Executives at Biogen Idec, the leading seller of MS drugs, reported the death during a conference call with analysts Wednesday after releasing stronger than anticipated third-quarter financial results. The company’s shares plunged $17.70 to $309.07, a loss of 5.4 percent on the Nasdaq stock exchange.

If it is confirmed that Tecfidera caused the brain infection, it would be the first time a PML case was tied to Biogen Idec’s multiple sclerosis pill. Tecfidera was approved by the Food and Drug Administration for US sale in March 2013. It has been used by more than 100,000 patients since the company began testing it in clinical trials more than 10 years ago.

http://www.bostonglobe.com/business/...hxJ/story.html

[ActiveMSers]

Concerns about the potential side effects of Biogen Idec Inc. ’s key multiple-sclerosis pill Tecfidera overshadowed the strong third-quarter results the biotech company posted Wednesday.

Biogen said on its conference call that it confirmed a case of a rare brain infection in a patient who took Tecfidera and recently died from complications of pneumonia.

Worries about progressive multifocal leukoencephalopathy, or PML, in patients taking multiple-sclerosis drugs date back more than 10 years to Biogen’s other MS treatment Tysabri. That drug was pulled from the market in 2005 after three patients in clinical trials contracted PML, though it was reintroduced the following year.

Biogen, which said it believes Tecfidera’s risk profile hasn’t changed, added the patient was treated with Tecfidera for four and a half years and had low white blood cell counts for most of that time.

http://online.wsj.com/articles/bioge...-37-1413978489