The death of a patient who had taken Biogen Idec Inc's new multiple sclerosis drug, Tecfidera, was unlikely to be linked to the medicine, the company said on Monday.
Biogen said it was made aware last week of the death of a 59-year-old woman who had been treated with Tecfidera, and that it was actively gathering facts about the case.
Based on the circumstances of the case and the cause of death, "a link to Tecfidera is unlikely," said Biogen spokeswoman Kate Niazi-Sai.
"The patient was not on Tecfidera at the time of death," she added.
Tecfidera, which is widely expected to become the No. 1 oral treatment for the disease, with annual sales of more than $3 billion, was launched in April. Biogen is expected to report sales for the drug's first few weeks on the market on Thursday.
The patient had taken Tecfidera for a little over five weeks, but discontinued using the drug due to gastrointestinal (GI) problems, such as vomiting and diarrhea, Biogen said.
She had been off the drug for more than two weeks prior to her death, which was reported as caused by a type of pneumonia more common to MS patients and not due to GI events, the company added.
The death was first reported by BioPharm Insight, and it briefly sent the company's shares down more than 3 percent before they rebounded. They closed up 0.6 percent at $231.67 on Nasdaq.
"I see this as a non-issue," Mark Schoenebaum, an analyst at ISI Group, told clients in an email.