FDA Warning: PML Death Associated With Biogen Idec's Tecfidera

Published: Nov 26, 2014

FDA Warning: PML Death Associated With Biogen Idec's Tecfidera

November 26, 2014

By Krystle Vermes, BioSpace.com Breaking News Staff

The U.S. Food and Drug Administration announced on Nov. 25 that a patient who was being treated for multiple sclerosis died of a rare, serious brain infection after receiving Biogen Idec ’s drug Tecfidera for treatment. The drug, also known as dimethyl fumarate, has been shown to help patients living with the disease, but will now carry a new warning placed on medication labels to alert physicians and patients to side effects.

The brain infection, known as progressive multifocal leukoencephalopathy (PML), may initially present itself as new or worsening weakness in the body. Additionally, a patient may start to have issues with eyesight, strength or balance. Biogen Idec, the creator of the drug, notified the FDA after a patient died from PML after taking Tecfidera for four years.

Tecfidera has been shown to help MS patients reduce attacks or relapses. In clinical trials, approximately 4,000 patients took the drug, and Biogen Idec claims that more than 100,000 patients have taken the drug since it was approved by the FDA in 2013.

The warning label that will be placed on packages of Tecfidera will mention the possibility of PML.

Plegridy Receives FDA Approval
Biogen still has an MS candidate in its pipeline. In August, Biogen Idec announced that the FDA had approved Plegridy, also known as peginterferon beta-1a, for people who have relapsing forms of multiple sclerosis. This drug is a pegylated beta interferon approved for use in patients with RMS.

“Plegridy offers people with MS robust efficacy, a safety profile consistent with the established interferon class, and significantly fewer injections than other beta interferon treatments,” said George Scangos, chief executive officer of Biogen Idec. “Plegridy represents the most significant innovation in the interferon class in over a decade, and is the result of our deep commitment to improving the lives of people with MS and those who care for them.”

In the first year of an ADVANCE clinical trial, the drug showed that it could significantly reduce the annualized relapse rate in patients with RMS. This was after the medication was given to patients once every two weeks. The most common adverse effects were fever, headache and muscle pain.

“Plegridy is a compelling new treatment option for people living with MS that offers a proven safety profile, strong efficacy and an every two week dosing schedule administered by an innovative delivery system,” said Peter Wade, medical director for neurology at the Mandell Center for Comprehensive Multiple Sclerosis Care and Neuroscience Research. “As a treating neurologist, I believe these attributes will appeal to MS patients who look for less frequent dosing with proven effectiveness.”

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