July 16, 2015 /
Non-fatal case is the second one for the oral MS drug.
by Kristina Fiore Staff Writer, MedPage Today
There’s been a second case of progressive multifocal leukoencephalopathy (PML) with dimethyl fumarate (Tecfidera) for multiple sclerosis, a Biogen spokesperson confirmed.
It occurred in a patient with primary progressive MS who had prolonged severe lymphopenia, which is on the drug’s label as a risk factor for PML, according to Biogen spokesperson Catherine Falcetti.
There’s been a second case of progressive multifocal leukoencephalopathy (PML) with dimethyl fumarate (Tecfidera) for multiple sclerosis, a Biogen spokesperson confirmed.
The company said it reported the case — which wasn’t fatal — to regulators including the FDA but would not specify where the case occurred
It occurred in a patient with primary progressive MS who had prolonged severe lymphopenia, which is on the drug’s label as a risk factor for PML, according to Biogen spokesperson Catherine Falcetti.
“It’s very similar to what we saw with the other case,” Falcetti told MedPage Today. “It’s within the risk profile, and the risk-benefit ratio remains favorable.”
The other PML case with Tecfidera, reported in the New England Journal of Medicineearlier this year, occurred in a 54-year-old woman with MS, who had severe lymphopenia for 3.5 years.
Another case of PML was reported at that time, but it occurred in a patient who was taking a compounded formulation of dimethyl fumarate for psoriasis
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