When a 59-year-old woman who had used Biogen Idec's Tecfidera died in July, the company said it was investigating but declared it was unlikely her death was tied to its new multiple sclerosis pill. Now the company says her doctor has made the determination the drug is not to blame.
A Biogen ($BIIB) spokeswoman told The Wall Street Journal that the patient's physician concluded her use of Tecfidera was not the reason for her death, and the company agreed. "The case has been assessed and it was determined that the death was unrelated to Tecfidera," the spokeswoman told the newspaper.
The patient had stopped taking Tecfidera about 2 1/2 weeks before her death because of gastrointestinal side effects. She had been using the drug for a little over 5 weeks at the time. The company had said the patient had a history of irritable bowel disease as well as recurring infections like bronchitis. At the time of her death she was suffering from a form of pneumonia that tends to afflict MS patients.
Tecfidera hit the market earlier this year and has been going gangbusters ever since. Biogen reported $192 million in first-quarter sales--more than twice the $70 million analysts had expected. Analysts, and the company, have big expectations for this drug, with forecasts putting sales at $3.8 billion in 2018.
Tecfidera actually comes without the safety concerns tied to competitors like Sanofi's ($SNY) Aubagio, with known liver risks, and Novartis' ($NVS) Gilenya, with heart-rate issues that recently prompted an FDA review. Still, it is not unusual for safety worries to arise as a new drug is rolled out to the general patient population, which typically is a more diverse group than the subset selected to participate in clinical trials.
- read the Wall Street Journal story (sub. req.)
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