If you did the “Ice Bucket Challenge” in 2014, you may have helped fund a new drug for ALS. Some experts are fond of its FDA approval; others less so.
In most patients, symptoms get worse over time, causing respiratory failure that leads to death within three to five years of the onset of the disease, according to Eufrosina Young, board-certified neurologist and ALS specialist at the Upstate University Hospital's department of neurology.
"There's just a general concern out there that maybe the trial is wrong," David Rind, chief medical officer for the Institute for Clinical and Economic Review, toldFor experts like Rind, some of the hesitancy can be attributed to the fact that FDA approval of Relyvrio was made after just oneNormally, for a drug to become FDA-approved, two smaller independent studies, with less than 1,000 patients, showing similar results or one large study with positive results across the board...
"Across the board, everybody wants a bigger trial, and everybody wants more evidence," she says,"But I think at the end of the day we can all agree, too, that a majority of ALS patients do not have that time."
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