Patient Death Link to New MS Drug 'Unlikely'

Pauline Anderson


July 24, 2013

On the basis of the circumstances of the recent death of a 59-year-old woman who had been treated with the multiple sclerosis (MS) drug dimethyl fumarate (BG-12, Tecfidera), her death is unlikely to be linked to the drug, according to a statement released by the public affairs department of Biogen Idec, the drug's manufacturer.

Tecfidera is a first-line oral medication recently approved in the United States for the treatment of adults with relapsing-remitting MS, the most common form of the disease. Pivotal studies showed the drug significantly reduces important measures of disease activity, including relapses and development of brain lesions and, in 1 trial, slowing disability progression over time, while demonstrating a favorable safety and tolerability profile.

The Biogen statement notes that the company was made aware of the woman's death late last week. The patient is believed to have been receiving Tecfidera for 5.5 weeks and discontinued the drug because of gastrointestinal events (nausea, vomiting, and diarrhea), after which the symptoms resolved. The patient discontinued treatment 2.5 weeks before her death, the company notes.

The cause of death was reported to be bilateral pneumonia, a condition that occurs more frequently in patients with MS. It was not due to gastrointestinal events as has been reported in the media, a company representative said in a statement to Medscape Medical News.

The woman had a history of irritable bowel disease and recurrent infections, including bronchitis.

According to a report by Reuters, Tecfidera is widely expected to become the number 1 oral treatment for the disease, with annual sales of more than $3 billion. Biogen is expected to report sales for the drug's first few weeks on the market on Thursday.

The first report of the death by BioPharm Insight briefly sent the company's shares down more than 3% before they rebounded, closing up 0.6% at $231.67 on the Nasdaq, the Reuters report adds.

"As part of our ongoing pharmacovigilance processes, Biogen Idec is actively gathering facts about this case," said the statement. "Further follow-up on this case is ongoing according to our standard pharmacovigilance practices and regulatory requirements, and we will share additional information as appropriate."


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