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Biogen reports death of patient taking Tecfidera

10/28/2014

Pharmaceutical firm Biogen Idec Inc. reported last week that a patient who took Tecfidera for four-and-a-half years died after being infected with progressive multifocal leukoencephalopathy, PML.

Biogen Idec spokeswoman Kate Niazi-Sai told the Boston Globe that even though the patient officially died of pneumonia and that its MS drug was not directly linked to the death, Biogen “can’t rule out Tecfidera as playing a role.”

Dr. Ben Thrower, a member of the Multiple Sclerosis Foundation’s Medical Advisory Board, said that progressive multifocal leukoencephalopathy is a serious viral infection of the brain, sometimes resulting in death. According to news reports, the company reported the death during a conference call with analysts.

"We have confirmed a case of PML in a patient being treated with Tecfidera, who recently died from complications of pneumonia. Despite this tragic loss, we believe that the overall positive benefit/risk profile of Tecfidera remains unchanged," Biogen Chief Executive Officer George Scangos said on the call.

Niazi-Sai told the Globe that the company would not release the age, gender or identity of the individual. Scangos told analysts the patient had severe lymphopenia, or low white blood cell counts, for three-and-a-half of the four-and-a-half years the patient had been taking the drug.

“This case illustrates the need for regular monitoring of blood counts in patients on Tecfidera,” said Dr. Thrower. “The current recommendations are for a CBC within 6 months of starting Tecfidera and then annually or sooner if indicated. My personal feeling is that these recommendations are not enough. At (the Shepard Center) we do blood testing, including a CBC and more sensitive T-cell subset analysis, before starting Tecfidera and then every three months.”

Since entering the U.S. market in March 2013, more than 100,000 patients have taken Tecfidera. Scangos said Tecfidera's label contains a warning for lymphopenia, a known risk factor for PML.

“I suspect that new FDA guidelines will be issued that will suggest more rigorous safety monitoring,” said Dr. Thrower. “While this case of PML is serious and our hearts go out to the patient and his family, it does not mean everyone needs to stop Tecfidera. It does mean that the risks and benefits need to be discussed and that more frequent lab testing should be considered.”



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