The Food and Drug Administration has issued a negative review of a closely watched experimental drug for the debilitating illness known as Lou Gehrig’s disease
But the reviewers found the drug had “only a modest” effect on slowing the disease's progression in a 137-patient, mid-stage study, which reviewers said was plagued with implementation and analysis problems. Typically, FDA approval requires two large studies or one study with a “very persuasive” effect on survival.
After further discussions with regulators last summer, Amylyx decided to submit its drug for approval based on the initial study plus survival data gathered afterwards. The company said that data showed patients who took the drug lived about six months longer than those taking a dummy drug. Wednesday's meeting marks the first time FDA has convened this advisory panel since disregarding its advice last June and approving Biogen’sAlzheimer’s drug, Aduhelm. Three panel members resigned over the controversial decision and congressional investigators launched a probe into FDA’s handling of the drug’s review. As in the current case, the FDA faced intense pressure from patient groups to grant approval.
The ALS Association, which helped fund Amylyx’s research, said the FDA’s review does not take into account “the speed and severity of ALS and the few treatment options available.”
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