FDA: Highly rated Alzheimer’s drug: Biogen, Eisai
FDA: Alzheimer’s drug
On October 6, an advisory board consisting of outside experts was held.
Safety and efficacy of aducanumab:
FDA staff and Biogen explained the safety and efficacy of aducanumab.
Advisory Board Report:
“A report compiled by FDA staff before this week’s advisory board meeting,” pointed out.
It was a positive sign for future approval.
FDA staff said yesterday that two trials of aducanumab had conflicting results.
Two exams:
One pointed out that it showed “high and extremely convincing” effectiveness.
Another test result said, “The results were not good, but there is no evidence that they are not valid.”
The FDA has called on the Advisory Board to vote on whether the results of a positive clinical trial are sufficient to determine that the drug is effective.
The FDA is expected to make a decision on approval by early March next year.
https://www.bloomberg.co.jp/news/articles/2020-11-04/QJA35IT1UM1501
Biogen Shares Surge After FDA Publishes Alzheimer’s Documents
About 5.8 million Americans
are living with Alzheimer’s dementia, according to the Alzheimer’s Association.Other approved drugs
temporarily improve some symptoms, but none slow or stop the destruction of brain neurons that causes symptoms and eventually kills, the association said in a report last year.Biogen, based in Cambridge, Massachusetts, presented data from the two aducanumab trials at a conference in December.
One trial showed the drug may slow the progression of the disease, while the other found no effect.
Researchers questioned the positive results because not all participants completed the trials.
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