New Psoriasis And Multiple Sclerosis Treatment Drug Linked Deadly Brain Disease

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The active ingredient in a drug that’s expected to become a popular Multiple Sclerosis Treatment has been linked to four European cases of a rare but sometimes fatal brain disease called progressive multifocal leukoencephalopathy (PML).The ingredient, dimethyl fumarate, is used in a drug called Fumaderm that was approved in Germany in 1994 to treat the skin condition psoriasis. It is also in a different but closely related medication called Tecfidera, which was just approved by the U.S. Food and Drug Administration in March for Multiple Sclerosis Treatment.
It is known as a fumaric acid ester, which is commonly used as a food additive and has been used to treat psoriasis in Germany for 30 years.According to reports published in the April 25 issue of the New England Journal of Medicine, however, three patients who were taking Fumaderm to treat their psoriasis developed PML. One other patient developed the brain condition after taking a separate medication from a compounding pharmacy that also contained dimethyl fumarate.

In a letter responding to the reports, Biogen, the company that makes both drugs, said Tecfidera may be safer because it contains only dimethyl fumarate, while Fumaderm also contains three other fumaric acid esters.The company also noted that none of the patients taking Tecfidera during clinical trials (then known as BG-12) developed PML. Since Tecfidera is a pill rather than an injection, and was effective and well-tolerated by patients in clinical trials, analysts have predicted it would soon become the top-selling multiple sclerosis treatment.