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FDA panel urges rejection of experimental Alzheimer's drug [View all]
Source: Associated Press
FDA panel urges rejection of experimental Alzheimer’s drug
By MARILYNN MARCHIONE and MATTHEW PERRONE
November 6, 2020
WASHINGTON (AP) — Government health advisers sharply criticized a closely watched Alzheimer’s drug on Friday, concluding there wasn’t enough evidence that the experimental drug slowed the brain-destroying disease.
The panel of outside experts for the Food and Drug Administration agreed that a pivotal study in patients failed to show “strong evidence” that the drug worked. The experts warned of multiple “red flags” with the data, which did not initially show any benefit until another analysis with later results.
“Alzheimer’s treatment is a huge, urgent, unmet need,” said panelist Dr. Joel Perlmutter, of Washington University School of Medicine. “But if we approve something with data that is not strong we have the risk of delaying good, effective treatments.”
He was one of eight panelists who voted against the drug’s evidence; one voted that the drug showed “strong evidence” and two members said they were undecided. The panel also rejected the merits of a second study of the drug.
The FDA is not required to follow the group’s guidance but their negative opinion could weigh heavily on the agency’s decision on whether to greenlight the drug. The FDA is expected to make a decision by March.
-snip-
By MARILYNN MARCHIONE and MATTHEW PERRONE
November 6, 2020
WASHINGTON (AP) — Government health advisers sharply criticized a closely watched Alzheimer’s drug on Friday, concluding there wasn’t enough evidence that the experimental drug slowed the brain-destroying disease.
The panel of outside experts for the Food and Drug Administration agreed that a pivotal study in patients failed to show “strong evidence” that the drug worked. The experts warned of multiple “red flags” with the data, which did not initially show any benefit until another analysis with later results.
“Alzheimer’s treatment is a huge, urgent, unmet need,” said panelist Dr. Joel Perlmutter, of Washington University School of Medicine. “But if we approve something with data that is not strong we have the risk of delaying good, effective treatments.”
He was one of eight panelists who voted against the drug’s evidence; one voted that the drug showed “strong evidence” and two members said they were undecided. The panel also rejected the merits of a second study of the drug.
The FDA is not required to follow the group’s guidance but their negative opinion could weigh heavily on the agency’s decision on whether to greenlight the drug. The FDA is expected to make a decision by March.
-snip-
Read more: https://apnews.com/article/dementia-alzheimers-disease-8ce05b6c22ca4e649d299bb3abafe43a
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