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Saturday, January 11, 2014

MS Patient Fights FDA Over Rejection Of Genzyme's Lemtrada

Jan 10, 2014 

A 49-year-old mother from Waterford, Conn., has become an ally of Cambridge, Mass.-based drug giant Genzyme in its efforts to get U.S. regulators to change their minds about the first-ever once-a-year drug to treat multiple sclerosis.
Melissa Burdick, who was diagnosed with the degenerative disease 13 years ago, has filed a citizen’s petition requesting that the U.S. Food and Drug Administration approves Lemtrada. The drug was recently been approved in Canada, Australia and Europe, but was denied late last year by the FDA due to a disagreement over the way the drug trials were conducted.
For Burdick, the drug represents the most promising out of a quickly narrowing range of options for treating the inflammatory disease, which affects the brain and nervous system. Burdick was taking the interferon-based drug, Avonex, for eight years, before it became ineffective. She then took another drug, called Tysabri, for the next five years, saying “it’s been wonderful,” but had to stop last October due to risk of a deadly infection of the brain’s white matter called PML. Both Avonex and Tysabri were created and are marketed by Cambridge-based Biogen Idec.
While there are seven other drugs approved in the U.S. for MS, most of them either won’t work on her or would carry too great a risk of other health problems, she said.
“I have gone through all the different options,” she said. Lemtrada, on the other hand, is “a brand new way of looking at the disease,” she said. The infused drug essentially eliminates all of the body’s T-cells, and then allows them to replenish themselves, and Burdick said she’s known people who have taken the trug in a trial years ago who have never needed it again.
Burdick, who works in the business office of a local hospital, attended a meeting last November in which an FDA advisory panel gave contradictory recommendations as to whether the drug should be approved. The disagreement came down to whether the 1,400 patients in the trial should have been told which drug they were taking to avoid bias. The FDA prefers blind trials, but Genzyme argued that there’s no way it could have prevented patients from figuring out whether they were receiving Lemtrada or the drug it was being compared to, EMD Serono’s drug, Rebif.
“The FDA was just bashing (Genzyme) horribly (at the meeting), because they thought they should have done a blind study,” said Burdick.
She filed her citizen’s petition in late November, after the hearing but before the drug was officially rejected. She knows, however, that hers is an uphill battle. According to FDA documents, out of 20 appeals filed to overturn FDA decisions in 2012, just two were granted. The previous year, 13 appeals were filed and none were granted.

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