Currently the FDA is expected to review the committee’s opinion and then decide whether to approve the drug or pump the brake. That decision may not come for a while – it may not come next year.
Approval will mark an important milestone; it will be the first approval of a new Alzheimer’s cure in nearly 20 years.
On the question of whether it makes sense to consider data from a positive study the primary evidence of aducanumab̵7;s effectiveness in treating Alzheimer’s disease, none of the committee members voted in favor. – 10 people vote no and one is unsure.
The panel of experts questioned the drug’s effectiveness
In response to a question about whether positive research provides “strong evidence” that supports aducanumab’s effectiveness in treating Alzheimer’s disease, one committee member voted yes, eight people voted no and you’re not sure.
And to answer a private question about whether another smaller study provided supportive evidence about the effectiveness of aducanumab, none of the committee members voted in agreement – seven people voted no and four are unsure.
Dr Joel Perlmutter, a committee member who voted “no” on questions about whether evidence supports aducanumab’s effectiveness, said: “There is a huge risk in approving something. inefficient.”
“If we approve something when the data is not strong enough, we risk delaying good and effective treatments for more than a few years, for years,” Perlmutter said at a meeting on Friday. , ”Perlmutter said during Friday’s meeting.
Committee member, Dr. G. Caleb Alexander, who also voted “no” or “unsure” for the questions, agreed: “This is such an important application to get it right because asking too. big on new treatments. “
The panel member was ‘very critical’ of the FDA’s presentation
During the meeting, some committee members also raised concerns that the questions and data presented to the panel were biased, “one-sided” or in favor of the drug.
“I really criticized the fact that the FDA presentation today was too heavy to draw the same conclusions as the sponsor did,” said committee member, Dr. Scott Emerson, of Biogen.
Earlier in the meeting, Alexander said, “I found the document that the FDA provided was inappropriate.”
“We will continue to work with the FDA once the agency completes the review of our application,” Michel Vounatsos, Biogen’s chief executive, said in the statement.
FDA may decide to contradict the committee’s vote count and approve aducanumab. But such a decision would be controversial.
Rudolph Tanzi, Harvard neurology professor and director of the Genetic and Aging Research Unit at Massachusetts General Hospital, told CNN on Wednesday: “Who can expect this advisory committee to have more affect. He did not participate in the meeting.
In March 2019, the aducanumab phase 3 clinical trials were discontinued because of a futile analysis that the trials were incapable of meeting key goals on completion.
But a few months later, Biogen announced that a new analysis, including more patients, showed that aducanumab users had a significant reduction in clinical decline in one trial. Results for several patients in another study also support these findings.
Then in July, Biogen completed its submission to the FDA for a Biological License Application for drug approval.
If approved, aducanumab would become the first immunotherapy to reduce the clinical decline of Alzheimer’s disease and also the first to demonstrate that the removal of beta amyloid, a marker of degenerative disorder brain, for better clinical results.
A bunch of ‘completely different opinions’
Michael Carome, the group’s director, said in a written statement Thursday the approval of the drug “is likely to do more harm than good.”
Opinions vary between clinicians and researchers on whether aducanumab should be approved, said Dr. Richard Isaacson, director of the Alzheimer’s Prevention Clinic at Weill Cornell Medicine and New York. -Presbyterian in New York, who had the patient in the initial aducanumab clinical studies, told CNN on Wednesday.
“A handful of the most respected scientists and researchers in our field have a completely different opinion,” said Isaacson. “Whatever the decision is, it’s a pivotal moment in the area of Alzheimer’s disease.”