When headlines hit the news such as last week’s announcement that cases of PML have occurred with a medication containing the same active ingredient as Biogen Idec’s newly approved Tecfidera (BG12, oral dimethyl fumarate), I have a need to know the whole story. Fortunately, I was able to access the case studies and company’s response published in the New England Journal of Medicine (NEJM).
Only weeks following the approval of Tecfidera (oral dimethyl
fumarate), also known as BG-12, for the treatment of relapsing forms of
multiple sclerosis, the headlines have been scattered with mentions of
PML, or progressive multifocal leukoencephalopathy.
In the April 25, 2013 issue of the New England Journal of Medicine (NEJM),
two separate cases involving patients in Europe diagnosed with
psoriasis who developed PML while taking different forms of dimethyl
fumarate. Dimethyl fumarate is the active ingredient found in Fumaderm®
(fumaric acid esters) tablets and Tecfidera™ (dimethyl fumarate)
delayed release capsules made by Biogen Idec. The cases studies are
described in Letters to the Editor in NEJM with a response provided by Biogen.
Read this post in its entirety:
Tecfidera and PML: Is there a direct connection?