The FDA is now expected to consider the committee’s views and then decide whether to approve the drug or pump the brakes. That decision doesn’t happen for a while – probably not until next year.
Approval will be a key target; It will be the first approval of a new Alzheimer’s drug in about 20 years.
In response to a question about whether it is reasonable to consider the data of a positive study as primary evidence of the effectiveness of educanumab for the treatment of Alzheimer’s disease, none of the committee members said yes – 10 voted and one was uncertain.
The expert panel questions the effectiveness of the drug
In response to the question of whether positive studies provide “strong evidence” to support the effectiveness of educanumab for the treatment of Alzheimer’s disease, one committee member voted in favor, eight voted in favor and two were undecided.
And in response to a separate question as to whether supporting evidence of Educanumab’s effectiveness was provided by another small study, none of the committee members said yes – seven voted and four were uncertain.
A member of the committee who voted “no” in response to questions as to whether the evidence supports the effectiveness of the educumumb. “There’s a big danger of approving something that doesn’t become effective,” said Joel Pearlmutter.
“If we allow something when the information is not strong, there is a risk of delaying good treatment and effective treatment for many, many years,” Pearlmutter said at Friday’s meeting.
Committee member Dr. G. Caleb Alexander, who also called the questions “no” or “uncertain”, agreed: “This is an important application to be appropriate due to the urgent need for a new treatment.”
Panel member FDA’s presentation ‘too complicated’
During the meeting, some members of the committee also expressed concern that the questions and data were presented to the panel in a way that was biased, “one-sided” or drug-friendly.
“I am very critical of the fact that the FDA’s presentation today was too weighty to give the same conclusions as made by the sponsor,” said committee member Dr. Scott Emerson said referring to Biogen.
At the beginning of the meeting, Alexander said, “I find the material provided by the FDA very inconsistent.”
“We will continue to work with the FDA as it completes the review of our application,” Michelle Vanatosos, Biogen’s chief executive, said in a statement.
The FDA may disagree with the committee’s votes and decide to approve the educumb. But such a decision would be controversial.
“One would expect this advisory committee to be very influential,” Rudolf Tanzi, a Harvard professor of neurology and director of the genetics and aging research unit at Massachusetts General Hospital, told CNN on Wednesday. He was not involved in the meeting.
In March 2019, UC Duknumb’s Phase 3 clinical trials were discontinued because futile analysis revealed that tests were unlikely to meet their primary targets once completed.
But several months later, Biogen announced that a new analysis, which included more patients, showed that those who received educanumab experienced a significant reduction in clinical decline in one trial. The results of some patients in another study also supported those findings.
Then in July, Biogen completed a submission to the FDA for a biologic license application for drug approval.
If approved, adjuvant b will become the first immunotherapy to reduce the clinical decline of Alzheimer’s disease and demonstrate that the removal of amyloid beta, a symptom of degenerative brain disorder, is the result of more clinical outcomes.
An array of ‘completely different opinions’
The group’s director, Michael Carrom, said in a written statement Thursday that approving the drug “does more harm than good.”
Richard Isaacson, director of the Alzheimer’s Prevention Clinic in New York and a New York-based presbyterian of New York, whose patients were originally from Educanum Clinical Studies, told CNN that there are various questions about whether Educanumab should be approved. On wednesday
“Many respected scientists and researchers in our field have completely different views,” Isaacs said. “Whatever the decision, it’s a reservoir for the field of Alzheimer’s disease.”
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