FDA Warns of Rare Brain Infection Associated With MS Drug Tecfidera
The FDA has added a warning about risks of a rare brain infection associated with Biogen Idec’s multiple sclerosis drug Tecfidera, after the first confirmed death of a patient taking the drug.
The MS patient who acquired progressive multifocal leukoencephalopathy (PML) was not taking any other drugs that might affect the immune system or are thought to be associated with the infection, the FDA said last week.
In October, Biogen Idec said that despite the death, it believes the overall positive benefit-risk profile of Tecfidera (dimethyl fumarate) remains unchanged. The company will continue working with the FDA to address information that physicians and patients need about Tecfidera, a spokeswoman said.
In its drug safety communication, the FDA noted the patient had been taking the drug for more than four years. Prior to developing the infection, she had a very low number of lymphocytes in her blood. It is unknown whether the low lymphocyte count contributed to developing PML in this patient, or if low lymphocyte counts are a risk factor for PML development in Tecfidera-treated patients, the FDA said.
Tecfidera, which treats relapsing forms of MS, received FDA approval last year. — Jonathon Shacat
Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.