Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease
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Public Comments
| Commenter | Comment Information |
|---|---|
| Nafe, Fhelica | Date: 01/31/2022 Comment: This dryg should be covered by Medicare. |
| Popowski, Christine | Organization: TerrariumTreasures Date: 01/31/2022 Comment: |
| Doresy, Ann | Date: 01/31/2022 Comment: The Food and Drug Administration’s (FDA’s) decision to approve Aduhelm for treatment of Alzheimer’s disease showed a stunning disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged. The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the |
| Greeley, David | Title: MD Organization: Northwest Neurological, PLLC Date: 01/30/2022 Comment: I write today as a third-generation physician and a clinical neurologist and researcher for almost thirty years. With over fifty people enrolled at my clinic I was one of the top investigators for the EMERGE trial — and I still have over twenty in EMBARK — the open-label extension of that trial. I also now have an additional twenty plus patients on Aduhelm® — who started it after it was FDA-approved — and another fifty plus waiting for CMS (and/or a Medicare Advantage plans) to make a |
| Reynolds, Diana | Date: 01/30/2022 Comment: The Food and Drug Administration’s (FDA’s) decision to approve Aduhelm for treatment of Alzheimer’s disease showed a stunning disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged. The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the |
| McGinley, Megan | Date: 01/30/2022 Comment: The Food and Drug Administration’s (FDA’s) decision to approve Aduhelm for treatment of Alzheimer’s disease showed a stunning disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged. The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the |
| Maniex, Nicholas | Date: 01/30/2022 Comment: The Food and Drug Administration’s (FDA’s) decision to approve Aduhelm for treatment of Alzheimer’s disease showed a stunning disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged. The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the |
| Maniex, Ashley | Date: 01/30/2022 Comment: The Food and Drug Administration’s (FDA’s) decision to approve Aduhelm for treatment of Alzheimer’s disease showed a stunning disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged. The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the |
The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials if continued to completion, were unlikely to show the drug benefitted Alzheimer’s disease patients. Moreover, the integrity of the FDA’s review of the marketing application for Aduhelm was dangerously corrupted by the unprecedented and inappropriately close collaboration between Biogen and the FDA
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