Ingredient in New MS Drug Linked to Serious Brain Disease
Reports found four psoriasis patients who took similar drug developed rare but sometimes deadly condition
By Brenda Goodman
WEDNESDAY, April 24 (HealthDay News) -- The active ingredient in a drug that's expected to become a popular treatment for multiple sclerosis 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 the treatment of multiple sclerosis (MS). 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.
But the German doctor who treated one of the psoriasis patients who got PML thinks there is still cause for concern.
Dr. Jorg Schulz, a neurologist at Rheinisch-Westfaelische Technische Hochschule Aachen, a research university in Aachen, said the two drugs are virtually identical once they are broken down in the body.
"The problem is that the studies with BG-12 covered a two-year period, but no longer periods," Schulz said, and he believes it may take prolonged treatment with the drug for PML to surface.
"With the publication of our case, we wish to create awareness that treatment with any form of fumaric acid may bear the risk of developing PML," Schulz said.
In their response, Biogen countered that while patients had been only tracked for an average of two years at the time Tecfidera received FDA approval for MS, many of the patients in these trials have now been on the drug for five years with no reports of PML. The company added that over the 20 years that German patients have used Fumaderm, only three case reports of PML have arisen, and those cases involved additional risk factors for the illness.