. The review comes ahead of a meeting this week for outside experts to vote on the drug for ALS. The drug has been the focal point of a lobbying campaign by patients, their families and lawmakers. FDA reviewers said Monday, March 28, 2022 the single study from Amylyx Pharmaceuticals was “not persuasive” due to missing data, errors in enrolling patients and other problems.
The FDA's negative stance on the drug sets up a tense scenario at Wednesday's public session, where several dozen ALS patients and advocates are scheduled to speak. The agency will consider the input from its advisory panel before making a final decision on the drug, expected by June. 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.
But FDA says the results are unreliable because of problems tracking the study participants for several years. 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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